Poster presented at the 36th Fall Clinical Dermatology Conference | Las Vegas, NV | October 12-15, 2017

Burden of Axillary Hyperhidrosis Using a Patient-Reported Outcome Measure to Assess Impact on  
Activities and Bothersomeness
David M. Pariser,1 Adelaide A. Hebert,2 Janice Drew,3 John Quiring,4 Dee Anna Glaser5 
1Eastern Virginia Medical School and Virginial Clinical Research, Inc., Norfolk, VA; 2UTHealth McGovern Medical School at Houston, Houston, TX; 3Dermira, Inc., Menlo Park, CA; 4QST Consultations, Allendale, MI; 5Saint Louis University, St. Louis, MO

INTRODUCTION
• Hyperhidrosis, which is estimated to affect 4.8% of the US population 

or approximately 15.3 million people, is associated with considerable 
impairment in work productivity, social activities, emotional well-being, 
and personal relationships1,2

• Topical glycopyrronium tosylate (GT; formerly DRM04), a cholinergic 
receptor antagonist, has been assessed in 2 replicate randomized 
phase 3 clinical trials (ATMOS-1 and ATMOS-2) for the treatment of 
primary axillary hyperhidrosis in patients ≥9 years of age; the primary 
efficacy and safety results of these studies have been previously 
reported3

• Patient-reported outcomes (PROs) from these pivotal trials were also 
assessed using the 4-item Axillary Sweating Daily Diary (ASDD),4 6 Weekly 
Impact items, and the single-item Patient Global Impression of Change 
(PGIC), that were developed according to current regulatory standards 

OBJECTIVE 
• To evaluate the burden of disease associated with primary axillary 

hyperhidrosis utilizing PRO measures reported at Baseline for patients 
who participated in ATMOS-1 and ATMOS-2

METHODS
ATMOS-1 and ATMOS-2 Study Design
• ATMOS-1 (NCT02530281; sites in the US and Germany) and 

ATMOS-2 (NCT02530294; US sites only) were parallel-group, 4-week, 
double-blind, phase 3 clinical trials in which patients with primary 
axillary hyperhidrosis were randomized (2:1) to GT or vehicle (Figure 1)

• For the purposes of this analysis, data from the GT and vehicle groups 
from each study have been pooled

• Eligible patients were ≥9 years of age and had primary axillary 
hyperhidrosis for ≥6 months, with gravimetrically-measured sweat 
production of ≥50 mg/5 min in each axilla, ASDD axillary sweating 
severity item (Item 2) score ≥4, and Hyperhidrosis Disease Severity 
Scale (HDSS) grade 3 or 4 

• Patients were excluded for history of a condition that could cause 
secondary hyperhidrosis; prior surgical procedure or treatment 
with a medical device for axillary hyperhidrosis; treatment with 
iontophoresis within 4 weeks or treatment with botulinum toxin for 
axillary hyperhidrosis within 1 year; axillary use of nonprescription 
antiperspirant within 1 week or prescription antiperspirant within 2 
weeks; new or modified psychotherapeutic medication regimen within 
2 weeks; treatment with medications having systemic anticholinergic 
activity, centrally acting alpha-2 adrenergic agonists, or beta-blockers 
within 4 weeks unless dose had been stable ≥4 months and was not 
expected to change; and/or conditions that could be exacerbated by 
study medication

Figure 1.  Study Design

Week 0 Week 4

ATMOS-1 and ATMOS-2

Target
Recruitment:
330 patients

randomized 2:1

GT

Vehicle

Burden of Disease Measures
• Axillary Hyperhidrosis Patient Measures (AHPM)

 – The ASDD consists of 4 items and was used for patients ≥16 years; 
patients <16 years of age completed a modified, child-specific, 2-item 
version called the ASDD-C (Table 1)

 – Patients ≥16 years were additionally asked to complete 6 Weekly 
Impact items and a single-item Patient Global Impression of Change 
(PGIC; Table 1)

• The burden of disease associated with primary axillary hyperhidrosis was 
summarized by descriptive statistics in the intent-to-treat (ITT) population 
(all randomized subjects who were dispensed study drug) based on:

 – Mean score at Baseline on ASDD axillary sweating severity item 
(Item 2; all patients) and items addressing the impact and bother of 
sweating (Items 3 and 4, respectively; patients ≥16 years of age); 
Baseline was defined as the average of ≥4 days of data in the most 
recent 7 days prior to randomization

 – Mean score at Baseline for Weekly Impact items (patients ≥16 years of 
age); Baseline was defined as the last available record prior to Day 1

• An additional analysis was performed to assess the proportion of 
patients with moderate-to-severe axillary sweating, impact, and bother, 
defined as scores of 9 or 10 on ASDD Item 2 and scores of 3 or 4 on 
ASDD Items 3 and 4, respectively

 

Table 1.  Axillary Hyperhidrosis Patient Measures 
(AHPM)a

Axillary Sweating Daily Diary (ASDD)b 
Instructions: The questions in the diary are designed to measure the severity and 
impact of any underarm sweating you have experienced within the previous 24 hour 
period, including nighttime hours. While you may also experience sweating in other 
locations on your body, please be sure to think only about your underarm sweating 
when answering these questions. 
Please complete the diary each evening before you go to sleep.

Item 1 
[Gatekeeper]

During the past 24 hours, did you have any underarm sweating?
Yes/No  
When Item 1 is answered “no,” Item 2 is skipped and scored as zero

Item 2
During the past 24 hours, how would you rate your underarm sweating at 
its worst?
0 (no sweating at all) to 10 (worst possible sweating) 

Item 3
During the past 24 hours, to what extent did your underarm sweating 
impact your activities?
0 (not at all), 1 (a little bit), 2 (a moderate amount), 3 (a great deal), 4 (an 
extreme amount)

Item 4
During the past 24 hours, how bothered were you by your underarm 
sweating? 
0 (not at all bothered), 1 (a little bothered), 2 (moderately bothered), 3 (very 
bothered), 4 (extremely bothered)

Axillary Sweating Daily Diary-Children (ASDD-C)c 
Instructions: These questions measure how bad your underarm sweating was last 
night and today. Please think only about your underarm sweating when answering 
these questions. 
Please complete these questions each night before you go to sleep.

Item 1
[Gatekeeper]

Thinking about last night and today, did you have any underarm sweating? 
Yes/No 
When Item 1 is answered “no,” Item 2 is skipped and scored as zero

Item 2 Thinking about last night and today, how bad was your underarm sweating? 0 (no sweating at all) to 10 (worst possible sweating)

Weekly Impact Itemsb

Instructions: Please respond “Yes” or “No” to each of the following questions.

a.  During the past 7 days, did you ever have to change your shirt during the day 
because of your underarm sweating?

Yes/
No

b.  During the past 7 days, did you ever have to take more than 1 shower or bath 
a day because of your underarm sweating?

Yes/
No

c.  During the past 7 days, did you ever feel less confident in yourself because of 
your underarm sweating?

Yes/
No

d.  During the past 7 days, did you ever feel embarrassed by your underarm 
sweating?

Yes/
No

e.  During the past 7 days, did you ever avoid interactions with other people 
because of your underarm sweating?

Yes/
No

f.  During the past 7 days, did your underarm sweating ever keep you from doing 
an activity you wanted or needed to do?

Yes/
No

Patient Global Impression of Change (PGIC) Itemb 
Overall, how would you rate your underarm sweating now as compared to before starting 
the study treatment?
1 (much better), 2 (moderately better), 3 (a little better), 4 (no difference), 5 (a little worse), 
6 (moderately worse), 7 (much worse)

aASDD/ASDD-C Item 2 is a validated PRO measure
bFor use in patients ≥16 years of age
cFor use in patients ≥9 to < 16 years of age

RESULTS
• A total of 697 patients were randomized and were asked to complete 

ASDD/ASDD-C Items 1 and 2; 665 patients were ≥16 years of age 
and were asked to complete items addressing the impact and bother of 
sweating (Items 3 and 4, respectively), and the Weekly Impact items

• Demographics and Baseline disease characteristics were similar between 
studies (Table 2)

Table 2.  Baseline Demographic and Disease 
Characteristics (ITT Populations)

ATMOS-1
(N=344)

ATMOS-2
(N=353)

Demographics
Age (years), mean ± SD 32.7 ± 11.9 32.6 ±11.0
Age group, n (%)

<16 years 
≥16 years

  11 (  3.2) 
333 (96.8)

  21 (  5.9) 
332 (94.1)

Male, n (%) 154 (44.8) 172 (48.7)
White, n (%) 276 (80.2) 294 (83.3)
BMI (kg/m2), mean ± SD 27.5 ± 5.5 27.7 ± 5.2

Baseline Disease Characteristics
Years with primary axillary hyperhidrosis, 
mean ± SD 14.5 ± 10.7 16.5 ±10.7

Sweat production (mg/5 min)a, mean ± SD 178.7 ± 237.4 168.9 ± 153.2
HDSSb, n (%)

Grade 3 
Grade 4

217 (63.1) 
127 (36.9)

215 (60.9) 
137 (38.8)

ASDD Item 2c, mean ± SD 7.2 ± 1.7 7.3 ± 1.6
aGravimetrically measured
bHDSS grade 3 or 4 was an inclusion criteria for the study
cAverage of daily records from the 7 days prior to date of first dose; a minimum of 4 days was required to compute the average
ASDD, Axillary Sweating Daily Diary; BMI, body mass index; HDSS, Hyperhidrosis Disease Severity Score; ITT, intent-to-treat

• At Baseline in ATMOS-1 and ATMOS-2, the mean ± SD ASDD/ASDD-C 
axillary sweating severity item (Item 2) scores were 7.2 ± 1.6 and 
7.3 ± 1.6, respectively

 – In each trial, more than half of all patients reported weekly average 
scores ≥7 before randomization, indicating that patients considered 
their sweating to be moderate or severe at Baseline (Figure 2)

 – 16.0% and 19.3% of patients rated the severity of their axillary 
sweating as 9 or 10 in ATMOS-1 and ATMOS-2, respectively, 
indicating severe axillary hyperhidrosis at Baseline (Figure 2) 

Figure 2.  Proportion of Patients Reporting 
Moderate-to-Severe Axillary Sweating at 
Baseline (ASDD/ASDD-C Item 2 Scores) 

59.3% 59.8%

Average Score ≥7

16.0%
19.3%

Average Score 9 or 10

ATMOS-1 (N=344)
ATMOS-2 (N=353)

80

100

60

40

20

0

B
as

el
in

e 
A

S
D

D
 It

em
 2

 S
co

re
s,

 
%

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at
ie

nt
s

Data are representative of the intent-to-treat (ITT) population
ASDD Item 2: During the past 24 hours, how would you rate your underarm sweating at its worst? 0 (no sweating at all) to 10 
(worst possible sweating)
ASDD-C Item 2: Thinking about last night and today, how bad was your underarm sweating? 0 (no sweating at all) to 10 (worst 
possible sweating)
ASDD, Axillary Sweating Daily Diary; ASDD-C, ASDD-Children

• At Baseline in ATMOS-1 and ATMOS-2, mean ± SD ASDD Item 3 
(impact of axillary sweating) scores were 2.3 ± 0.9 and 2.4 ± 0.9, 
respectively

 – In each trial, approximately 70% of patients ≥16 years of age reported 
scores ≥2 on ASDD Item 3, indicating that their daily activities were 
at least moderately affected by axillary hyperhidrosis at Baseline 
(Figure 3)

 – 26.2% and 29.7% of patients were severely impacted by axillary 
sweating in ATMOS-1 and ATMOS-2, respectively, having reported 
scores of 3 or 4 at Baseline (Figure 3) 

Figure 3.  Proportion of Patients Reporting 
Moderate-to-Severe Impact of Axillary 
Sweating at Baseline (ASDD Item 3 Scores) 

69.4%
71.7%

Average Score ≥2

26.2%
29.7%

Average Score 3 or 4

ATMOS-1 (N=344)
ATMOS-2 (N=353)

80

100

60

40

20

0

B
as

el
in

e 
A

S
D

D
 It

em
 3

 S
co

re
s,

 
%

 o
f P

at
ie

nt
s

Data are representative of the intent-to-treat (ITT) population
ASDD Item 3: During the past 24 hours, to what extent did your underarm sweating impact your activities?
0 (not at all), 1 (a little bit), 2 (a moderate amount), 3 (a great deal), 4 (an extreme amount)
ASDD, Axillary Sweating Daily Diary

• At Baseline in ATMOS-1 and ATMOS-2, the mean ± SD ASDD Item 4 
(bother of axillary sweating) scores were 2.6 ± 0.9 and 2.6 ± 0.9, 
respectively

 – In each trial, >75% of patients ≥16 years of age reported scores ≥2 on 
ASDD Item 4, indicating that they were at least moderately bothered 
by axillary sweating at Baseline (Figure 4)

 – 37.5% and 40.1% of patients were severely bothered by axillary 
sweating in ATMOS-1 and ATMOS-2, respectively, having reported 
scores of 3 or 4 at Baseline (Figure 4) 

Figure 4.  Proportion of Patients Reporting 
Moderate-to-Severe Bother of Axillary 
Sweating at Baseline (ASDD Item 4 Scores)  

77.8% 77.4%

Average Score ≥2

37.5%
40.1%

Average Score 3 or 4

ATMOS-1 (N=344)
ATMOS-2 (N=353)

80

100

60

40

20

0

B
as

el
in

e 
A

S
D

D
 It

em
 4

 S
co

re
s,

 
%

 o
f P

at
ie

nt
s

Data are representative of the intent-to-treat (ITT) population
ASDD Item 4: During the past 24 hours, how bothered were you by your underarm sweating? 0 (not at all bothered), 1 (a little 
bothered), 2 (moderately bothered), 3 (very bothered), 4 (extremely bothered)
ASDD, Axillary Sweating Daily Diary

• At Baseline, the majority of patients who were ≥16 years of age answered 
‘yes’ to questions asking if their underarm sweating affected their actions 
or emotions (Weekly Impact Items) during the past week (Figure 5)

 – Notably, more than 96% of patients reporting feeling embarrassed

Figure 5.  Proportion of Patients Answering ‘Yes’ to 
Weekly Impact Items 

83.9%
87.3%

a. Needed to
change shirt

during the day

60.4%
54.0%

b. Needed ≥1
shower/bath

a day

89.5%
93.0%

c. Felt less
confident

96.7% 96.3%

d. Felt
embarrassed

68.1%
65.0%

e. Avoided
interactions

58.2% 58.3%

f. Kept from
doing an
activity

ATMOS-1 (N=304)
ATMOS-2 (N=300)

80

100

60

40

20

0

%
 o

f P
at

ie
nt

s 
an

sw
er

in
g 

“Y
es

” 
to

 W
ee

kl
y 

Im
pa

ct
 It

em
s

Data are representative of the intent-to-treat (ITT) population

CONCLUSIONS
• At Baseline, more than half of all patients who participated in 

ATMOS-1 and ATMOS-2 reported that their sweating was at least 
a 7 on an 11-point scale where 0 represents no sweating and 10 
represents worst possible sweating

• In patients who were ≥16 years of age, axillary hyperhidrosis at 
least moderately affected their daily activities and was considered 
at least moderately bothersome

 – Approximately 1 in 5 patients reported experiencing severe 
axillary sweating

 – Approximately 1 in 3 reported feeling severely impacted and/or 
bothered by their sweating

• On a weekly basis, the majority of patients who were ≥16 years of 
age reported being markedly impacted by their excess sweating, with 
most having to avoid interactions or take additional measures (ie, 
showering/bathing more than once a day; changing shirts during the 
day) to manage their excessive sweating; more than 90% of patients 
were less confident or embarrassed by sweating

• These findings are consistent with previous reports that hyperhidrosis 
is associated with a substantial disease burden; as such, safe and 
effective new treatment options are needed for this disease

References
1. Doolittle et al. Arch Dermatol Res. 2016; 308 (10):743-9. 2. Hamm. Dermatology. 2006;212:343-53. 3. Pariser et al. Poster 
presented at: the 25th European Academy of Dermatology and Venereology Congress; September 28-October 2, 2016; Vienna, 
Austria. 4. Pariser et al. Poster presented at: 13th Annual Maui Derm for Dermatologists; March 20-24, 2017; Maui, HI. 

Acknowledgements 
The authors would like to thank Sheri Fehnel, Dana DiBenedetti, and Lauren Nelson, from RTI Health Solutions, as well as Diane 
Ingolia and Christine Conroy, from Dermira, Inc., for their work developing the PRO questionnaire. These studies were funded 
by Dermira, Inc. Medical writing support was provided by Prescott Medical Communications Group. All costs associated with 
development of this abstract were funded by Dermira, Inc.

Author Disclosures
DMP: Consultant and Investigator for Dermira, Inc.; AH: Consultant for Dermira, Inc.; employee of the University of Texas 
Medical School, Houston, which received compensation from Dermira, Inc. for study participation; JD: Employee of Dermira, Inc; 
JQ: Employee of QST Consultations; DAG: Consultant and Investigator for Dermira, Inc. .


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