Emmy Graber,1 Hilary Baldwin,2 Julie C. Harper,3 Linda Stein Gold,4 Andrew F. Alexis,5 Richard G. Fried,6 Evan A Rieder,7 James Del Rosso,8 Leon Kircik,9  
Siva Narayanan,10 Volker Koscielny,11 Ismail Kasujee,11 Adelaide Hebert12

1The Dermatology Institute of Boston and Northeastern University, Boston, MA; 2Acne Treatment and Research Center, Brooklyn, NY; 3The Dermatology and Skin Care Center of Birmingham, Birmingham, 
AL; 4Henry Ford Health System, Bloomfield, MI;  5Weill Cornell Medical College, New York, NY; 6Yardley Dermatology Associates, Yardley, PA; 7New York University Grossman School of Medicine, New 

York, NY; 8JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 9Icahn School of Medicine, Mount Sinai, New York, NY, 
10Avant Health LLC, Bethesda, MD; 11Almirall SA, Barcelona, Spain; 12UTHealth McGovern Medical School, Houston, TX.

INVESTIGATOR GLOBAL ASSESSMENT (IGA) OF ACNE VULGARIS AND IGA SUCCESS AMONG PATIENTS WITH MODERATE TO 
SEVERE NON-NODULAR ACNE VULGARIS (AV) ADMINISTERED SARECYCLINE IN COMMUNITY PRACTICES ACROSS THE U.S: 

PROSES STUDY ANALYSIS BY GENDER AND AGE

Introduction: The objective of this analysis was to 
evaluate facial IGA and the associated IGA success, 
stratified by age and gender, among AV patients 
administered sarecycline in community practices across 
the U.S. 
Methods: A single-arm, prospective cohort study 
(PROSES) was conducted with moderate-to-severe non-
nodular AV patients >9 years who were prescribed 
sarecycline in real-world community practices in the US. 
Facial IGA of AV status was collected on a five-point 
adjectival response scale (0(clear)-4(severe)). IGA 
success at week-12 was defined as >2-grade 
improvement and score 0-clear or 1-almost clear at 
week-12. Proportion of patients achieving IGA success 
was analyzed, stratified by gender and age (9-17yrs, 
>=18yrs).
Results: A total of 253 AV patients completed the study 
(female: 66.40%; 9-17yrs: 39.92%; >=18yrs: 60.08%; 
Facial IGA success at week-12 was 56.47% for male 
and 60.12% for female; 57.43% for patients 9-17yrs old 
and 59.87% for patients >=18yrs old.
Conclusion: Within the study cohort of adolescent and 
adult patients with moderate to severe AV at baseline 
administered sarecycline, a narrow-spectrum, 
tetracycline-derived antibiotic for 12 weeks, across the 
gender and age groups, majority of patients achieved 
IGA success at week-12.

SYNOPSIS

CONCLUSIONS
• Within the study cohort of adolescent and adult 

patients with moderate to severe AV at baseline 
administered sarecycline, a narrow-spectrum, 
tetracycline-derived antibiotic for 12 weeks, across the 
gender and age groups, majority of patients achieved 
IGA success at week-12.

Sponsored by Almirall, S.A.

METHODS
• A single-arm, prospective cohort study (PROSES) was 

conducted with moderate-to-severe non-nodular AV 
patients ≥9 years who were prescribed sarecycline in 
real-world community practices in the US. 

• A total of 300 subjects were enrolled from 30 
community practices across the U.S.

• Facial IGA of AV status was collected on a five-point 
adjectival response scale (0 (clear), 1 (almost-clear), 2 
(mild), 3 (moderate), 4 (severe)) at baseline and 
weeks 4, 8 & 12. 

• IGA success at week-12 was defined as ≥2-grade 
improvement and score 0-clear or 1-almost clear at 
week-12. 

• Last observation carried forward (LOCF) imputation 
was considered for imputing missing data for the 
calculation of IGA and IGA success; however, there 
was no missing data at week-12, within the analytic 
population.

• Proportion of patients achieving IGA success was 
analyzed, stratified by gender and age (9-17yrs, 
≥18yrs).

OBJECTIVE
• The objective of this analysis was to evaluate facial 

IGA and the associated IGA success, stratified by age 
and gender, among AV patients administered 
sarecycline in community practices across the U.S. 

RESULTS

Table 2: Patient Demographics (N=253)

Demographic Group Proportion of Patients

Age Group, %
Pediatric (<18 yrs) 39.92

Adult (≥18 yrs) 60.08

Age Group, Mean
Pediatric (<18 yrs) 26.63

Adult (≥18 yrs) 14.81

Gender, %
Male 33.60

Female 66.40

Race,%

White 66.80

Other 15.81

Black/African American 9.88

Asian 5.93

Prefer not to answer 3.16

American Indian or 
Alaskan

0.79

Native Hawaiian/Pacific 
Islander 0.40

Ethnicity,%
(Hispanic, Latino or 
of Spanish Origin) 

Yes 33.99

No 66.01

Baseline IGA, %
Moderate 86.56

Severe 13.44

• A total of 253 AV patients completed the study at week-12 with 58.90% of patients 
achieving IGA success by week-12. 

• The proportion of patients with an IGA of clear/almost clear increased from 0% at 
baseline to 58.90% at Week-12 (p<0.0001). Proportion of patients with IGA success 
stratified by gender and age group as shown in Figures 1 & 2 receptively.

• There was no statistically significant difference in IGA success between genders and 
between age groups. 

RESULTS

0.00%

5.94%

27.72%

57.43%

0.00%

11.84%

38.16%

59.87%

0%

10%

20%

30%

40%

50%

60%

70%

Baseline Week-4 Week-8 Week-12

P
ro

po
rti

on
 o

f P
at

ie
nt

s

Figure 2: Clinician Acne Evaluation of Patient Facial IGA Success: 
Stratified by age group

Patients ≥ 9 and < 18 years (N=101) Patients ≥ 18 years (N=152)

0.00%

5.88%

30.59%

56.47%

0.00%

10.71%

35.71%

60.12%

0%

10%

20%

30%

40%

50%

60%

70%

Baseline Week-4 Week-8 Week-12

P
ro

po
rti

on
 o

f P
at

ie
nt

s

Figure 1: Clinician Acne Evaluation of Patient Facial IGA Success: 
Stratified by Gender

Male (N=85) Female (N=168)

Table 1: Site Characteristics
Domain N=30

Current workplace, %
Private, office-based practice 100.00
Hospital-based practice 0.00

Total number of board-certified dermatologists 
in the practice, %

3.10

At present, how many patients with acne 
vulgaris do you personally manage in a given 
month? Mean

86.90

How long have you been practicing 
dermatology, post-residency?

19.30

How often do you prescribe broad-spectrum 
antibiotics (such as doxycycline and  
minocycline)? %

Never 0.00
Rarely 3.33
Some of the time 36.67
Most of the time 33.33
All of the time 26.67

IGA Success

IGA Success