Patient Concerns and Treatment Satisfaction in Patients Treated With Azelaic Acid Foam for Rosacea 
Williamson T1; Cameron J1; McLeod K2; Turner B2; Quillen A2; LaRose A1

Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ, USA; 2Xcenda, Palm Harbor, FL, USA

SPONSORSHIP: This research was sponsored by Bayer HealthCare Pharmaceuticals.Presented at the 2018 Winter Clinical Dermatology Conference, January 12-17, 2018; Lahaina, Hawaii

SYNOPSIS
• Rosacea is a common, chronic, inflammatory skin disorder affecting the 

convexities of the central face and can be categorized into 4 main subtypes: 
erythematotelangiectatic, papulopustular, phymatous, and ocular.1,2

• Regardless of subtype, non-pharmacologic or behavioral interventions are useful 
for the management of skin flares; however, for patients with mild to moderate 
cases, especially of papulopustular rosacea, topical therapies are usually used as 
first-line therapy.1,3

• The use of topical medications, including metronidazole and azelaic acid gel, 
has shown efficacy in clinical trials vs placebo in reducing inflammatory lesion 
counts in patients with papulopustular rosacea; however, these treatments 
were associated with higher incidences of post-application skin discomfort, as 
patients reported burning, itching, and stinging sensations.1,2,4-6 

• Formulations like azelaic acid foam have the potential to offer improvements 
over the side effect profiles of these treatment options.

OBJECTIVE
• This study aimed to survey patients with rosacea about their concerns, treatment 

satisfaction, and quality of life (QoL) associated with their azelaic acid foam 
treatment.

METHODS
STUDY DESIGN

• The study utilized a non-interventional, prospective, observational design and 
enrolled participants via email in collaboration with a patient support program, 
the Rosacea Concierge Program.

• A cross-sectional design was used to assess key patient concerns, treatment 
satisfaction, and QoL related to azelaic acid foam for rosacea.

SAMPLE SELECTION

• 2,150 patients from the United States (US) who were enrolled in the Rosacea 
Concierge Program were invited to participate in the study. 

• All inclusion and exclusion criteria were patient reported.

• Inclusion criteria:

− At least 18 years of age

− Diagnosis of rosacea by a medical professional

− Currently using azelaic acid foam as topical monotherapy for rosacea

− Willing and able to provide voluntary, informed consent to participate in  
the study

• Exclusion criteria:

− Use of any other topical treatment for rosacea at the time of enrollment

STUDY ENDPOINTS

• Eligible, consenting patients completed a 1-time survey assessing demographics, 
clinical characteristics (ie, rosacea-relevant comorbidities and complications), 
treatment history, and adverse events.

• Table 1 includes a brief overview of the 3 questionnaires included in the survey.

Figure 2. Patient Concerns With Rosacea Treatment

74.1% 

11.1% 
5.6% 5.6% 5.6% 5.6% 

1.9% 2.0% 2.0% 2.0% 0.0% 0.0% 0.0% 0.0% 
0%

20%

40%

60%

80%

100%

None Cost Efficacy Application Dryness Residue 
left on 
face 

Sun
sensitivity

Itching Scarring Burning Smell Soreness Stinging Texture

%
 o

f 
R

e
sp

o
n

d
e

n
ts

 R
e

p
o

rt
in

g
 C

o
n

ce
rn

 

Concern 

LIMITATIONS
• Due to the limited respondent pool, further research is needed to confirm these 

results.

− The International Society of Pharmacoeconomics and Outcomes Research (ISPOR) 
recommends that a minimum sample size of 200 patients is needed to obtain 
meaningful survey results in research on patient-reported outcomes. A total of 2,150 
patients were invited to participate in this study, and 150 responded; however, only 
54 met eligibility criteria and were enrolled in the study. 

CONCLUSION
• Azelaic acid foam was well tolerated and efficacious, with less than 26% of 

participants reporting any concerns or side effects and 6% reporting a concern 
with treatment efficacy.

• Azelaic acid foam users reported favorable results in the domains of burning, 
itching, and stinging.

• Due to the limited respondent pool, further research is needed to confirm these 
results. 

REFERENCES
1. Webster GF. Rosacea. Med Clin North Am. 2009;93(6):1183-1194.

2. Powell FC. Clinical practice. Rosacea. N Engl J Med. 352(8):793-803.

3. van Zuuren EJ, Kramer S, Carter B, Graber MA, Fedorowicz Z. Interventions for rosacea. Cochrane Database Syst Rev. 
2011;(3):CD003262.

4. Culp B, Scheinfeld N. Rosacea: a review. P&T. 2009;34(1):38-45.

5. Berg M, Liden S. An epidemiological study of rosacea. Acta Dermatol Venereol. 1989;69:419-423.

6. Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: report of the National Rosacea Society Expert Committee 
on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002;(4):584-587.

Table 2. Baseline Characteristics and Rosacea-relevant Medical Conditions

Total, N=54

Gender, n (%)
Female 49 90.7

Male 5 9.3

Age (years)

Mean (standard deviation) 48.1 (9.4)

Min 26.0  -

Median 48.5  -

Max 63.0  -

Health insurance 
coverage type, n 
(%)

Preferred provider organization 41 75.9

Health maintenance organization 8 14.8

Worker’s compensation/motor 
vehicle/third-party liability

0 0.0

Medicaid 2 3.7

Medicare/Medicare supplemental 0 0.0

Indemnity 0 0.0

Other 5 9.3

Rosacea-relevant 
medical conditions,  
n (%)

None 42 77.8

Depression 5 9.3

Migraine 5 9.3

Conjunctivitis 4 7.4

Blepharitis 1 1.9

Corneal neovascularization/keratitis 0 0

PATIENT ATTRITION

• Study recruitment and patient attrition are summarized in Figure 1. 

• 2,150 program-identified patients were invited to participate, 150 patients 
responded, and 54 met all eligibility criteria and were included in the study. 

RESULTS

Figure 1. Study Recruitment and Patient Attrition

Patients invited to 
participate in the study 
(n=2,150)

Eligible patients 
included in the study 
(n=54)

Patients responding to 
the invitation (n=150)

Ineligible

Not using azelaic acid foam 
as monotherapy (n=50, 36.0%)

•

Incomplete survey (n=43, 28.7%)•

No diagnosis of rosacea by a 
medical professional (n=2, 1.3%)

•

Repeat survey responses 
(n=1, 0.7%)

•

Figure 6. Mean SATMED-Q Scores

58.4 

2.5 

70.8 
76.1 

51.7 

75.9 79.0 

0 

20 

40 

60 

80 

100 

SATMED-Q score Undesirable 
side effects 

Treatment
effectiveness 

Convenience 
of use

Impact on 
daily activities 

Medical care Global satisfaction 

M
e
a
n

 S
co

re
 

SATMED-Q Category 

Key: SATMED-Q – Satisfaction with Medicines Questionnaire.

DEMOGRAPHICS

• A total of 54 patients were included in the study. Patient population 
characteristics and rosacea medical history are described in Table 2.

• Participants were primarily female (90.7%), ranging in age from 26 to 63 years. 

• The majority of participants (77.8%) reported no rosacea-relevant medical 
conditions.

• The most common subtypes reported by study participants were 
erythematotelangiectatic and papulopustular (74.1% each), with 59.3% of 
participants reporting “mild” rosacea symptoms (16.7% “absent”; 24.1% 
“moderate”) in the 4 weeks before enrollment.

• Only 13.0% of patients reported no previous rosacea treatment.

Figure 3. Rosacea Treatment Concerns’ Mean Importance Scores

Cost Efficacy Application Dryness Residue Sun 
sensitivity 

Itching Scarring Burning Smell Soreness Stinging Texture 

9.3 
10.0 

9.0 
8.0 

6.3 

10.0 

8.0 8.0 

3.0 

0.0 0.0 0.0 0.0 
0 

2 

4 

6 

8 

10 

M
e

a
n

 I
m

p
o

rt
a

n
ce

S
co

re
 o

f 
C

o
n

ce
rn

Concern 

Figure 4. Side Effects With Rosacea Treatment

None Dryness Stinging Itching Redness/worsening
of rosacea

Burning Residue left 
on face 

Soreness Uneven 
skin tone 

Side Effect 

77.8% 

13.0% 
7.4% 5.6% 5.6% 3.7% 1.9% 0.0% 0.0% 

0% 

20% 

40% 

60% 

80% 

100% 

%
 o

f 
R

e
sp

o
n

d
e

n
ts

R
e

p
o

rt
in

g
 S

id
e

 E
ff

e
ct

  

Figure 5. Mean Importance Scores of Rosacea Treatment Side Effects

5.3 

2.5 

4.7 

8.3 

7.0 

2.0 

0.0 0.0 
0

2

4

6

8

10

Dryness Stinging Itching Redness/worsening 
of rosacea 

Burning Residue left 
on face 

Soreness Uneven 
skin tone 

M
e

a
n

 I
m

p
o

rt
a

n
ce

S
co

re
 o

f 
S

id
e

 E
ff

e
ct

 

Side Effect 

TREATMENT SATISFACTION AND QOL

• The global satisfaction (SATMED-Q) mean score was 79.0 and treatment 
effectiveness mean score was 70.8 (Figure 6). Standardized scores for the SATMED-Q  
ranged from 0 to 100, with an overall score of 59.3 indicating feeling neutral and 
each additional 13.4-point increase indicating a clinically meaningful movement 
toward satisfaction.

• The impact of rosacea on QoL was “minimal” (mean DLQI score: 2.35). DLQI scores 
ranged from 0 to 30 (with 0–1 indicating rosacea has no effect on QoL and 21–30 
indicating rosacea has an extremely large effect on QoL).

EXPLORATORY ANALYSIS

• In regression models used for the exploratory analysis, increasing dryness 
importance scores were significantly associated with worsening treatment 
satisfaction and QoL in SATMED-Q and DLQI.

• The most commonly reported topical agent for prior rosacea treatment was 
metronidazole gel (7.4%). 

PATIENT CONCERNS

• The majority of patients reported no concerns (74.1%) with their treatment 
(Figure 2). The biggest concern reported was cost (11.1% of patients), with a 
mean importance score (IS) on a 10-point scale of 9.3 (Figure 3).

Table 1. Questionnaires Included in the Patient Survey

Questionnaire Details

Rosacea Treatment 
Preference 
Questionnaire

• 9-question survey composed of both aided and unaided 
questions.

• Assesses patient self-reported rosacea subtype and severity 
and evaluates drug characteristics that contribute to patient 
satisfaction/dissatisfaction and treatment decisions with 
rosacea topical treatments.

• Respondents list up to 5 concerns as well as up to 5 side effects 
with their current topical rosacea treatment experienced in 
the past 4 weeks and rate the importance of each reported 
concern or side effect.

• Respondents rank a list of pre-identified issues with topical 
rosacea treatment (eg, efficacy, cost, texture, dryness, etc) on a 
scale of importance from 0 to 10 (with 0 = not at all important; 
10 = extremely important) in terms of how important the issue 
is when they consider using a new topical rosacea treatment.

SATMED-Q

• 17-question, validated, multidimensional, generic questionnaire 
designed for use in patients with any chronic disease treated with 
medicines measuring treatment satisfaction.

• Composed of 6 domains:
− Undesirable side effects (3 questions)
− Efficacy (3 questions)
− Convenience and ease of use (3 questions)
− Impact of medicine (3 questions)
− Medical follow-up/review (2 questions)
− Overall opinion (3 questions)

DLQI

• 10-question, widely used dermatology-related QoL tool.
• Questions are general and cover symptoms and feelings, daily 

activities, leisure, work and school, personal relationships, and 
treatment experience over the previous week.

Key: DLQI – Dermatology Life Quality Index; QoL – quality of life; SATMED-Q – Satisfaction with Medicines Questionnaire.

STATISTICAL ANALYSIS 

• All study analyses conducted were exploratory and descriptive in nature.

• The primary analysis population set included all patients who met the eligibility 
criteria and completed the survey.

− Baseline characteristics were calculated as mean values for continuous variables 
and percentages for categorical variables.

− Proportions of patients listing each concern or side effect related to azelaic 
acid foam in the Rosacea Treatment Preference Questionnaire were assessed. 

− All the importance or tolerability scores that patients assigned to each concern 
or side effect, the satisfaction score from the Satisfaction with Medicines 
Questionnaire (SATMED-Q), and the QoL score from the Dermatology Life 
Quality Index (DLQI) were computed and summarized using means standard 
deviations and medians as appropriate.

• As an exploratory analysis to assess the association between concerns and side 
effects vs overall treatment satisfaction and overall QoL, regression analyses were 
conducted.

•  A majority (77.8%) of patients reported no side effects (Figure 4). Dryness was 
the most commonly reported side effect (13.0%; IS: 5.3). Other side effects 
reported included stinging (7.4%, IS: 2.5), itching (5.6%; IS: 4.7), redness (5.6%; 
IS: 8.3), and burning (3.7%; IS: 7.0) (Figure 5).

Patient Concerns and Treatment Satisfaction in Patients 
Treated With Azelaic Acid Foam for Rosacea 

Williamson T1; Cameron J1; McLeod K2; Turner B2; Quillen A2; LaRose A1

Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ, USA; 2Xcenda, Palm Harbor, FL, USA

Continue >>



Patient Concerns and Treatment Satisfaction in Patients Treated With Azelaic Acid Foam for Rosacea 
Williamson T1; Cameron J1; McLeod K2; Turner B2; Quillen A2; LaRose A1

Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ, USA; 2Xcenda, Palm Harbor, FL, USA

SPONSORSHIP: This research was sponsored by Bayer HealthCare Pharmaceuticals.Presented at the 2018 Winter Clinical Dermatology Conference, January 12-17, 2018; Lahaina, Hawaii

SYNOPSIS
• Rosacea is a common, chronic, inflammatory skin disorder affecting the 

convexities of the central face and can be categorized into 4 main subtypes: 
erythematotelangiectatic, papulopustular, phymatous, and ocular.1,2

• Regardless of subtype, non-pharmacologic or behavioral interventions are useful 
for the management of skin flares; however, for patients with mild to moderate 
cases, especially of papulopustular rosacea, topical therapies are usually used as 
first-line therapy.1,3

• The use of topical medications, including metronidazole and azelaic acid gel, 
has shown efficacy in clinical trials vs placebo in reducing inflammatory lesion 
counts in patients with papulopustular rosacea; however, these treatments 
were associated with higher incidences of post-application skin discomfort, as 
patients reported burning, itching, and stinging sensations.1,2,4-6 

• Formulations like azelaic acid foam have the potential to offer improvements 
over the side effect profiles of these treatment options.

OBJECTIVE
• This study aimed to survey patients with rosacea about their concerns, treatment 

satisfaction, and quality of life (QoL) associated with their azelaic acid foam 
treatment.

METHODS
STUDY DESIGN

• The study utilized a non-interventional, prospective, observational design and 
enrolled participants via email in collaboration with a patient support program, 
the Rosacea Concierge Program.

• A cross-sectional design was used to assess key patient concerns, treatment 
satisfaction, and QoL related to azelaic acid foam for rosacea.

SAMPLE SELECTION

• 2,150 patients from the United States (US) who were enrolled in the Rosacea 
Concierge Program were invited to participate in the study. 

• All inclusion and exclusion criteria were patient reported.

• Inclusion criteria:

− At least 18 years of age

− Diagnosis of rosacea by a medical professional

− Currently using azelaic acid foam as topical monotherapy for rosacea

− Willing and able to provide voluntary, informed consent to participate in  
the study

• Exclusion criteria:

− Use of any other topical treatment for rosacea at the time of enrollment

STUDY ENDPOINTS

• Eligible, consenting patients completed a 1-time survey assessing demographics, 
clinical characteristics (ie, rosacea-relevant comorbidities and complications), 
treatment history, and adverse events.

• Table 1 includes a brief overview of the 3 questionnaires included in the survey.

Figure 2. Patient Concerns With Rosacea Treatment

74.1% 

11.1% 
5.6% 5.6% 5.6% 5.6% 

1.9% 2.0% 2.0% 2.0% 0.0% 0.0% 0.0% 0.0% 
0%

20%

40%

60%

80%

100%

None Cost Efficacy Application Dryness Residue 
left on 
face 

Sun
sensitivity

Itching Scarring Burning Smell Soreness Stinging Texture
%

 o
f 

R
e

sp
o

n
d

e
n

ts
 R

e
p

o
rt

in
g

 C
o

n
ce

rn
 

Concern 

LIMITATIONS
• Due to the limited respondent pool, further research is needed to confirm these 

results.

− The International Society of Pharmacoeconomics and Outcomes Research (ISPOR) 
recommends that a minimum sample size of 200 patients is needed to obtain 
meaningful survey results in research on patient-reported outcomes. A total of 2,150 
patients were invited to participate in this study, and 150 responded; however, only 
54 met eligibility criteria and were enrolled in the study. 

CONCLUSION
• Azelaic acid foam was well tolerated and efficacious, with less than 26% of 

participants reporting any concerns or side effects and 6% reporting a concern 
with treatment efficacy.

• Azelaic acid foam users reported favorable results in the domains of burning, 
itching, and stinging.

• Due to the limited respondent pool, further research is needed to confirm these 
results. 

REFERENCES
1. Webster GF. Rosacea. Med Clin North Am. 2009;93(6):1183-1194.

2. Powell FC. Clinical practice. Rosacea. N Engl J Med. 352(8):793-803.

3. van Zuuren EJ, Kramer S, Carter B, Graber MA, Fedorowicz Z. Interventions for rosacea. Cochrane Database Syst Rev. 
2011;(3):CD003262.

4. Culp B, Scheinfeld N. Rosacea: a review. P&T. 2009;34(1):38-45.

5. Berg M, Liden S. An epidemiological study of rosacea. Acta Dermatol Venereol. 1989;69:419-423.

6. Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: report of the National Rosacea Society Expert Committee 
on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002;(4):584-587.

Table 2. Baseline Characteristics and Rosacea-relevant Medical Conditions

Total, N=54

Gender, n (%)
Female 49 90.7

Male 5 9.3

Age (years)

Mean (standard deviation) 48.1 (9.4)

Min 26.0  -

Median 48.5  -

Max 63.0  -

Health insurance 
coverage type, n 
(%)

Preferred provider organization 41 75.9

Health maintenance organization 8 14.8

Worker’s compensation/motor 
vehicle/third-party liability

0 0.0

Medicaid 2 3.7

Medicare/Medicare supplemental 0 0.0

Indemnity 0 0.0

Other 5 9.3

Rosacea-relevant 
medical conditions,  
n (%)

None 42 77.8

Depression 5 9.3

Migraine 5 9.3

Conjunctivitis 4 7.4

Blepharitis 1 1.9

Corneal neovascularization/keratitis 0 0

PATIENT ATTRITION

• Study recruitment and patient attrition are summarized in Figure 1. 

• 2,150 program-identified patients were invited to participate, 150 patients 
responded, and 54 met all eligibility criteria and were included in the study. 

RESULTS

Figure 1. Study Recruitment and Patient Attrition

Patients invited to 
participate in the study 
(n=2,150)

Eligible patients 
included in the study 
(n=54)

Patients responding to 
the invitation (n=150)

Ineligible

Not using azelaic acid foam 
as monotherapy (n=50, 36.0%)

•

Incomplete survey (n=43, 28.7%)•

No diagnosis of rosacea by a 
medical professional (n=2, 1.3%)

•

Repeat survey responses 
(n=1, 0.7%)

•

Figure 6. Mean SATMED-Q Scores

58.4 

2.5 

70.8 
76.1 

51.7 

75.9 79.0 

0 

20 

40 

60 

80 

100 

SATMED-Q score Undesirable 
side effects 

Treatment
effectiveness 

Convenience 
of use

Impact on 
daily activities 

Medical care Global satisfaction 

M
e
a
n

 S
co

re
 

SATMED-Q Category 

Key: SATMED-Q – Satisfaction with Medicines Questionnaire.

DEMOGRAPHICS

• A total of 54 patients were included in the study. Patient population 
characteristics and rosacea medical history are described in Table 2.

• Participants were primarily female (90.7%), ranging in age from 26 to 63 years. 

• The majority of participants (77.8%) reported no rosacea-relevant medical 
conditions.

• The most common subtypes reported by study participants were 
erythematotelangiectatic and papulopustular (74.1% each), with 59.3% of 
participants reporting “mild” rosacea symptoms (16.7% “absent”; 24.1% 
“moderate”) in the 4 weeks before enrollment.

• Only 13.0% of patients reported no previous rosacea treatment.

Figure 3. Rosacea Treatment Concerns’ Mean Importance Scores

Cost Efficacy Application Dryness Residue Sun 
sensitivity 

Itching Scarring Burning Smell Soreness Stinging Texture 

9.3 
10.0 

9.0 
8.0 

6.3 

10.0 

8.0 8.0 

3.0 

0.0 0.0 0.0 0.0 
0 

2 

4 

6 

8 

10 

M
e

a
n

 I
m

p
o

rt
a

n
ce

S
co

re
 o

f 
C

o
n

ce
rn

Concern 

Figure 4. Side Effects With Rosacea Treatment

None Dryness Stinging Itching Redness/worsening
of rosacea

Burning Residue left 
on face 

Soreness Uneven 
skin tone 

Side Effect 

77.8% 

13.0% 
7.4% 5.6% 5.6% 3.7% 1.9% 0.0% 0.0% 

0% 

20% 

40% 

60% 

80% 

100% 

%
 o

f 
R

e
sp

o
n

d
e

n
ts

R
e

p
o

rt
in

g
 S

id
e

 E
ff

e
ct

  

Figure 5. Mean Importance Scores of Rosacea Treatment Side Effects

5.3 

2.5 

4.7 

8.3 

7.0 

2.0 

0.0 0.0 
0

2

4

6

8

10

Dryness Stinging Itching Redness/worsening 
of rosacea 

Burning Residue left 
on face 

Soreness Uneven 
skin tone 

M
e

a
n

 I
m

p
o

rt
a

n
ce

S
co

re
 o

f 
S

id
e

 E
ff

e
ct

 

Side Effect 

TREATMENT SATISFACTION AND QOL

• The global satisfaction (SATMED-Q) mean score was 79.0 and treatment 
effectiveness mean score was 70.8 (Figure 6). Standardized scores for the SATMED-Q  
ranged from 0 to 100, with an overall score of 59.3 indicating feeling neutral and 
each additional 13.4-point increase indicating a clinically meaningful movement 
toward satisfaction.

• The impact of rosacea on QoL was “minimal” (mean DLQI score: 2.35). DLQI scores 
ranged from 0 to 30 (with 0–1 indicating rosacea has no effect on QoL and 21–30 
indicating rosacea has an extremely large effect on QoL).

EXPLORATORY ANALYSIS

• In regression models used for the exploratory analysis, increasing dryness 
importance scores were significantly associated with worsening treatment 
satisfaction and QoL in SATMED-Q and DLQI.

• The most commonly reported topical agent for prior rosacea treatment was 
metronidazole gel (7.4%). 

PATIENT CONCERNS

• The majority of patients reported no concerns (74.1%) with their treatment 
(Figure 2). The biggest concern reported was cost (11.1% of patients), with a 
mean importance score (IS) on a 10-point scale of 9.3 (Figure 3).

Table 1. Questionnaires Included in the Patient Survey

Questionnaire Details

Rosacea Treatment 
Preference 
Questionnaire

• 9-question survey composed of both aided and unaided 
questions.

• Assesses patient self-reported rosacea subtype and severity 
and evaluates drug characteristics that contribute to patient 
satisfaction/dissatisfaction and treatment decisions with 
rosacea topical treatments.

• Respondents list up to 5 concerns as well as up to 5 side effects 
with their current topical rosacea treatment experienced in 
the past 4 weeks and rate the importance of each reported 
concern or side effect.

• Respondents rank a list of pre-identified issues with topical 
rosacea treatment (eg, efficacy, cost, texture, dryness, etc) on a 
scale of importance from 0 to 10 (with 0 = not at all important; 
10 = extremely important) in terms of how important the issue 
is when they consider using a new topical rosacea treatment.

SATMED-Q

• 17-question, validated, multidimensional, generic questionnaire 
designed for use in patients with any chronic disease treated with 
medicines measuring treatment satisfaction.

• Composed of 6 domains:
− Undesirable side effects (3 questions)
− Efficacy (3 questions)
− Convenience and ease of use (3 questions)
− Impact of medicine (3 questions)
− Medical follow-up/review (2 questions)
− Overall opinion (3 questions)

DLQI

• 10-question, widely used dermatology-related QoL tool.
• Questions are general and cover symptoms and feelings, daily 

activities, leisure, work and school, personal relationships, and 
treatment experience over the previous week.

Key: DLQI – Dermatology Life Quality Index; QoL – quality of life; SATMED-Q – Satisfaction with Medicines Questionnaire.

STATISTICAL ANALYSIS 

• All study analyses conducted were exploratory and descriptive in nature.

• The primary analysis population set included all patients who met the eligibility 
criteria and completed the survey.

− Baseline characteristics were calculated as mean values for continuous variables 
and percentages for categorical variables.

− Proportions of patients listing each concern or side effect related to azelaic 
acid foam in the Rosacea Treatment Preference Questionnaire were assessed. 

− All the importance or tolerability scores that patients assigned to each concern 
or side effect, the satisfaction score from the Satisfaction with Medicines 
Questionnaire (SATMED-Q), and the QoL score from the Dermatology Life 
Quality Index (DLQI) were computed and summarized using means standard 
deviations and medians as appropriate.

• As an exploratory analysis to assess the association between concerns and side 
effects vs overall treatment satisfaction and overall QoL, regression analyses were 
conducted.

•  A majority (77.8%) of patients reported no side effects (Figure 4). Dryness was 
the most commonly reported side effect (13.0%; IS: 5.3). Other side effects 
reported included stinging (7.4%, IS: 2.5), itching (5.6%; IS: 4.7), redness (5.6%; 
IS: 8.3), and burning (3.7%; IS: 7.0) (Figure 5).

Patient Concerns and Treatment Satisfaction in Patients 
Treated With Azelaic Acid Foam for Rosacea 

Williamson T1; Cameron J1; McLeod K2; Turner B2; Quillen A2; LaRose A1

Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ, USA; 2Xcenda, Palm Harbor, FL, USA

Continue >>



Patient Concerns and Treatment Satisfaction in Patients Treated With Azelaic Acid Foam for Rosacea 
Williamson T1; Cameron J1; McLeod K2; Turner B2; Quillen A2; LaRose A1

Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ, USA; 2Xcenda, Palm Harbor, FL, USA

SPONSORSHIP: This research was sponsored by Bayer HealthCare Pharmaceuticals.Presented at the 2018 Winter Clinical Dermatology Conference, January 12-17, 2018; Lahaina, Hawaii

SYNOPSIS
• Rosacea is a common, chronic, inflammatory skin disorder affecting the 

convexities of the central face and can be categorized into 4 main subtypes: 
erythematotelangiectatic, papulopustular, phymatous, and ocular.1,2

• Regardless of subtype, non-pharmacologic or behavioral interventions are useful 
for the management of skin flares; however, for patients with mild to moderate 
cases, especially of papulopustular rosacea, topical therapies are usually used as 
first-line therapy.1,3

• The use of topical medications, including metronidazole and azelaic acid gel, 
has shown efficacy in clinical trials vs placebo in reducing inflammatory lesion 
counts in patients with papulopustular rosacea; however, these treatments 
were associated with higher incidences of post-application skin discomfort, as 
patients reported burning, itching, and stinging sensations.1,2,4-6 

• Formulations like azelaic acid foam have the potential to offer improvements 
over the side effect profiles of these treatment options.

OBJECTIVE
• This study aimed to survey patients with rosacea about their concerns, treatment 

satisfaction, and quality of life (QoL) associated with their azelaic acid foam 
treatment.

METHODS
STUDY DESIGN

• The study utilized a non-interventional, prospective, observational design and 
enrolled participants via email in collaboration with a patient support program, 
the Rosacea Concierge Program.

• A cross-sectional design was used to assess key patient concerns, treatment 
satisfaction, and QoL related to azelaic acid foam for rosacea.

SAMPLE SELECTION

• 2,150 patients from the United States (US) who were enrolled in the Rosacea 
Concierge Program were invited to participate in the study. 

• All inclusion and exclusion criteria were patient reported.

• Inclusion criteria:

− At least 18 years of age

− Diagnosis of rosacea by a medical professional

− Currently using azelaic acid foam as topical monotherapy for rosacea

− Willing and able to provide voluntary, informed consent to participate in  
the study

• Exclusion criteria:

− Use of any other topical treatment for rosacea at the time of enrollment

STUDY ENDPOINTS

• Eligible, consenting patients completed a 1-time survey assessing demographics, 
clinical characteristics (ie, rosacea-relevant comorbidities and complications), 
treatment history, and adverse events.

• Table 1 includes a brief overview of the 3 questionnaires included in the survey.

Figure 2. Patient Concerns With Rosacea Treatment

74.1% 

11.1% 
5.6% 5.6% 5.6% 5.6% 

1.9% 2.0% 2.0% 2.0% 0.0% 0.0% 0.0% 0.0% 
0%

20%

40%

60%

80%

100%

None Cost Efficacy Application Dryness Residue 
left on 
face 

Sun
sensitivity

Itching Scarring Burning Smell Soreness Stinging Texture

%
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R

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sp

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Concern 

LIMITATIONS
• Due to the limited respondent pool, further research is needed to confirm these 

results.

− The International Society of Pharmacoeconomics and Outcomes Research (ISPOR) 
recommends that a minimum sample size of 200 patients is needed to obtain 
meaningful survey results in research on patient-reported outcomes. A total of 2,150 
patients were invited to participate in this study, and 150 responded; however, only 
54 met eligibility criteria and were enrolled in the study. 

CONCLUSION
• Azelaic acid foam was well tolerated and efficacious, with less than 26% of 

participants reporting any concerns or side effects and 6% reporting a concern 
with treatment efficacy.

• Azelaic acid foam users reported favorable results in the domains of burning, 
itching, and stinging.

• Due to the limited respondent pool, further research is needed to confirm these 
results. 

REFERENCES
1. Webster GF. Rosacea. Med Clin North Am. 2009;93(6):1183-1194.

2. Powell FC. Clinical practice. Rosacea. N Engl J Med. 352(8):793-803.

3. van Zuuren EJ, Kramer S, Carter B, Graber MA, Fedorowicz Z. Interventions for rosacea. Cochrane Database Syst Rev. 
2011;(3):CD003262.

4. Culp B, Scheinfeld N. Rosacea: a review. P&T. 2009;34(1):38-45.

5. Berg M, Liden S. An epidemiological study of rosacea. Acta Dermatol Venereol. 1989;69:419-423.

6. Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: report of the National Rosacea Society Expert Committee 
on the Classification and Staging of Rosacea. J Am Acad Dermatol. 2002;(4):584-587.

Table 2. Baseline Characteristics and Rosacea-relevant Medical Conditions

Total, N=54

Gender, n (%)
Female 49 90.7

Male 5 9.3

Age (years)

Mean (standard deviation) 48.1 (9.4)

Min 26.0  -

Median 48.5  -

Max 63.0  -

Health insurance 
coverage type, n 
(%)

Preferred provider organization 41 75.9

Health maintenance organization 8 14.8

Worker’s compensation/motor 
vehicle/third-party liability

0 0.0

Medicaid 2 3.7

Medicare/Medicare supplemental 0 0.0

Indemnity 0 0.0

Other 5 9.3

Rosacea-relevant 
medical conditions,  
n (%)

None 42 77.8

Depression 5 9.3

Migraine 5 9.3

Conjunctivitis 4 7.4

Blepharitis 1 1.9

Corneal neovascularization/keratitis 0 0

PATIENT ATTRITION

• Study recruitment and patient attrition are summarized in Figure 1. 

• 2,150 program-identified patients were invited to participate, 150 patients 
responded, and 54 met all eligibility criteria and were included in the study. 

RESULTS

Figure 1. Study Recruitment and Patient Attrition

Patients invited to 
participate in the study 
(n=2,150)

Eligible patients 
included in the study 
(n=54)

Patients responding to 
the invitation (n=150)

Ineligible

Not using azelaic acid foam 
as monotherapy (n=50, 36.0%)

•

Incomplete survey (n=43, 28.7%)•

No diagnosis of rosacea by a 
medical professional (n=2, 1.3%)

•

Repeat survey responses 
(n=1, 0.7%)

•

Figure 6. Mean SATMED-Q Scores

58.4 

2.5 

70.8 
76.1 

51.7 

75.9 79.0 

0 

20 

40 

60 

80 

100 

SATMED-Q score Undesirable 
side effects 

Treatment
effectiveness 

Convenience 
of use

Impact on 
daily activities 

Medical care Global satisfaction 

M
e
a
n

 S
co

re
 

SATMED-Q Category 

Key: SATMED-Q – Satisfaction with Medicines Questionnaire.

DEMOGRAPHICS

• A total of 54 patients were included in the study. Patient population 
characteristics and rosacea medical history are described in Table 2.

• Participants were primarily female (90.7%), ranging in age from 26 to 63 years. 

• The majority of participants (77.8%) reported no rosacea-relevant medical 
conditions.

• The most common subtypes reported by study participants were 
erythematotelangiectatic and papulopustular (74.1% each), with 59.3% of 
participants reporting “mild” rosacea symptoms (16.7% “absent”; 24.1% 
“moderate”) in the 4 weeks before enrollment.

• Only 13.0% of patients reported no previous rosacea treatment.

Figure 3. Rosacea Treatment Concerns’ Mean Importance Scores

Cost Efficacy Application Dryness Residue Sun 
sensitivity 

Itching Scarring Burning Smell Soreness Stinging Texture 

9.3 
10.0 

9.0 
8.0 

6.3 

10.0 

8.0 8.0 

3.0 

0.0 0.0 0.0 0.0 
0 

2 

4 

6 

8 

10 

M
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Concern 

Figure 4. Side Effects With Rosacea Treatment

None Dryness Stinging Itching Redness/worsening
of rosacea

Burning Residue left 
on face 

Soreness Uneven 
skin tone 

Side Effect 

77.8% 

13.0% 
7.4% 5.6% 5.6% 3.7% 1.9% 0.0% 0.0% 

0% 

20% 

40% 

60% 

80% 

100% 

%
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R

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R
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ct

  

Figure 5. Mean Importance Scores of Rosacea Treatment Side Effects

5.3 

2.5 

4.7 

8.3 

7.0 

2.0 

0.0 0.0 
0

2

4

6

8

10

Dryness Stinging Itching Redness/worsening 
of rosacea 

Burning Residue left 
on face 

Soreness Uneven 
skin tone 

M
e

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Side Effect 

TREATMENT SATISFACTION AND QOL

• The global satisfaction (SATMED-Q) mean score was 79.0 and treatment 
effectiveness mean score was 70.8 (Figure 6). Standardized scores for the SATMED-Q  
ranged from 0 to 100, with an overall score of 59.3 indicating feeling neutral and 
each additional 13.4-point increase indicating a clinically meaningful movement 
toward satisfaction.

• The impact of rosacea on QoL was “minimal” (mean DLQI score: 2.35). DLQI scores 
ranged from 0 to 30 (with 0–1 indicating rosacea has no effect on QoL and 21–30 
indicating rosacea has an extremely large effect on QoL).

EXPLORATORY ANALYSIS

• In regression models used for the exploratory analysis, increasing dryness 
importance scores were significantly associated with worsening treatment 
satisfaction and QoL in SATMED-Q and DLQI.

• The most commonly reported topical agent for prior rosacea treatment was 
metronidazole gel (7.4%). 

PATIENT CONCERNS

• The majority of patients reported no concerns (74.1%) with their treatment 
(Figure 2). The biggest concern reported was cost (11.1% of patients), with a 
mean importance score (IS) on a 10-point scale of 9.3 (Figure 3).

Table 1. Questionnaires Included in the Patient Survey

Questionnaire Details

Rosacea Treatment 
Preference 
Questionnaire

• 9-question survey composed of both aided and unaided 
questions.

• Assesses patient self-reported rosacea subtype and severity 
and evaluates drug characteristics that contribute to patient 
satisfaction/dissatisfaction and treatment decisions with 
rosacea topical treatments.

• Respondents list up to 5 concerns as well as up to 5 side effects 
with their current topical rosacea treatment experienced in 
the past 4 weeks and rate the importance of each reported 
concern or side effect.

• Respondents rank a list of pre-identified issues with topical 
rosacea treatment (eg, efficacy, cost, texture, dryness, etc) on a 
scale of importance from 0 to 10 (with 0 = not at all important; 
10 = extremely important) in terms of how important the issue 
is when they consider using a new topical rosacea treatment.

SATMED-Q

• 17-question, validated, multidimensional, generic questionnaire 
designed for use in patients with any chronic disease treated with 
medicines measuring treatment satisfaction.

• Composed of 6 domains:
− Undesirable side effects (3 questions)
− Efficacy (3 questions)
− Convenience and ease of use (3 questions)
− Impact of medicine (3 questions)
− Medical follow-up/review (2 questions)
− Overall opinion (3 questions)

DLQI

• 10-question, widely used dermatology-related QoL tool.
• Questions are general and cover symptoms and feelings, daily 

activities, leisure, work and school, personal relationships, and 
treatment experience over the previous week.

Key: DLQI – Dermatology Life Quality Index; QoL – quality of life; SATMED-Q – Satisfaction with Medicines Questionnaire.

STATISTICAL ANALYSIS 

• All study analyses conducted were exploratory and descriptive in nature.

• The primary analysis population set included all patients who met the eligibility 
criteria and completed the survey.

− Baseline characteristics were calculated as mean values for continuous variables 
and percentages for categorical variables.

− Proportions of patients listing each concern or side effect related to azelaic 
acid foam in the Rosacea Treatment Preference Questionnaire were assessed. 

− All the importance or tolerability scores that patients assigned to each concern 
or side effect, the satisfaction score from the Satisfaction with Medicines 
Questionnaire (SATMED-Q), and the QoL score from the Dermatology Life 
Quality Index (DLQI) were computed and summarized using means standard 
deviations and medians as appropriate.

• As an exploratory analysis to assess the association between concerns and side 
effects vs overall treatment satisfaction and overall QoL, regression analyses were 
conducted.

•  A majority (77.8%) of patients reported no side effects (Figure 4). Dryness was 
the most commonly reported side effect (13.0%; IS: 5.3). Other side effects 
reported included stinging (7.4%, IS: 2.5), itching (5.6%; IS: 4.7), redness (5.6%; 
IS: 8.3), and burning (3.7%; IS: 7.0) (Figure 5).

Patient Concerns and Treatment Satisfaction in Patients 
Treated With Azelaic Acid Foam for Rosacea 

Williamson T1; Cameron J1; McLeod K2; Turner B2; Quillen A2; LaRose A1

Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ, USA; 2Xcenda, Palm Harbor, FL, USA