ACKNOWLEDGEMENTS: Medical writing support was provided by Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics; Ortho Dermatologics is a division of Bausch Health US, LLC | Presented at Winter Clinical Dermatology Conference 2020 • January 17-22, 2020 • Kohala Coast, HI

SYNOPSIS

 ◾ Acne is a prevalent disease, occurring in 85% of adolescents1

 ◾ Prevalence in adults is increasing and it occurs more often in females than males2,3 

 ◾ In addition, older age and female sex are associated with a greater impact on quality of 
life (QoL)4

 ◾ The first lotion formulation of tretinoin 0.05%, developed by utilizing novel polymeric 
emulsion technology, was efficacious and well tolerated in two phase 3 studies of 
patients ≥9 years of age with moderate-to-severe acne (NCT02932306, NCT02965456)5

OBJECTIVE

 ◾ To assess efficacy and safety of tretinoin 0.05% lotion in females of various age groups 
with moderate-to-severe acne

METHODS

 ◾ In two phase 3 double-blind, randomized, multicenter, parallel-group, vehicle-controlled 
studies, patients ≥9 years of age with moderate-to-severe acne were randomized 1:1 to 
tretinoin 0.05% lotion or vehicle once daily for 12 weeks

• In this study, CeraVe® hydrating cleanser and CeraVe® moisturizing lotion (L’Oreal, NY) 
were provided as needed for optimal moisturization/cleaning of the skin

 ◾ Data from these 2 studies were pooled and analyzed post hoc in a subset of female 
patients by age: 13-19 years, 20-29 years; and 30+ years

 ◾ Efficacy assessments included reductions in inflammatory and noninflammatory lesions, 
percentage of patients achieving ≥2-grade reduction in Evaluator Global Severity Scores 
(EGSS), and Acne-Specific Quality of Life Questionnaire (Acne-QoL)

 ◾ Cutaneous safety and tolerability were also evaluated

RESULTS

Participants

 ◾ The pooled population included 865 female patients

• 13-19 years (tretinoin, n=173; vehicle, n=184)

• 20-29 years (tretinoin, n=163; vehicle, n=189)

• 30+ years (tretinoin, n=80; vehicle, n=76)

 ◾ The majority of patients in each age group had an EGSS score of 3 (moderate) at 
baseline (13-19 y, 93.3%; 20-29 y, 88.9%; 30+ y, 95.5%)

Efficacy

Within Age Groups (Treatment versus Vehicle)

 ◾ At week 12, least-squares mean percent reductions from baseline in inflammatory and 
noninflammatory lesion counts were significant versus vehicle in the tretinoin-treated 
13-19 year group; in the tretinoin-treated older age groups, reductions from baseline 
versus vehicle were only significant for noninflammatory lesions, which may be due to 
the limited number of patients in each group (Figure 1)

Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in Females:  
Effect of Age on Efficacy and Tolerability

FIGURE 2. Percentage of Participants Achieving ≥2-Grade Reduction 
in Evaluator Global Severity Scores by Age Group and Visit  
(ITT Population, Pooled)

#(

0%

10%

20%

30%

1.6%

Week 4

P
e
rc

e
n
ta

g
e
 o

f
P

a
rt

ic
ip

a
n
ts

5.2%

4.3%

2.0%

5.8%

4.6%Vehicle:

5.7%

Week 8

7.6%

12.8%

6.5%

15.2%

10.5%

#(

24.4%

Week 12

17.0%

25.9%

16.8%

30.7%

18.8%

40%
13-19 y (n=173)

20-29 y (n=163)

30+ y (n=80)

There were no significant differences across the 3 age groups at weeks 4, 8, or 12.   
Vehicle: 13-19 y (n=184); 20-29 y (n=189); 30+ y (n=76). 
Multiple imputation method used for missing values. ITT, intent-to-treat; LS, least squares.

FIGURE 3. Mean Change From Baseline at Week 12 in Quality of Life by Age 
Group (ITT Population, Pooled)

0

2

4

6

7.5

Self-perception

M
e
a
n
 P

e
rc

e
n
t 

C
h
a
n
g

e
 

F
ro

m
 B

a
se

lin
e

7.0

10.2

8.8

8.8

9.5Vehicle:

14
13-19 y (n=173)

20-29 y (n=163)

30+ y (n=80)

8

10

12

Im
p

ro
ve

m
e

n
t

6.7

Role-emotional

6.1

10.0

7.9

7.5

8.6

4.5

Role-social

3.8

6.5

6.5

6.4

7.2

5.2

Acne symptoms

5.1

9.1

7.4

8.1

7.6

**P≤0.01 vs vehicle.  
There were no significant differences across the 3 age groups at weeks 4, 8, or 12.   
Vehicle: 13-19 y (n=184); 20-29 y (n=189); 30+ y (n=76). 
Higher scores for each domain reflect improved health-related QoL. No imputation for missing values. ITT, intent-to-treat;  
QoL, quality of life.

Safety

 ◾ In the tretinoin-treated group, mean cutaneous safety and tolerability ratings were all 
between none (0) or mild (1) within each age group at weeks 4, 8, and 12 

 ◾ By week 12, any mild, transient increases in cutaneous safety and tolerability in each age 
group had returned to baseline values or improved (Figure 4)

 ◾ The percentage of patients achieving ≥2-grade EGSS reduction in each age group was 
greater with tretinoin treatment versus vehicle, though differences were not significant 
(Figure 2)

 ◾ QoL improvements at week 12 were significant versus vehicle in the tretinoin-treated 
20-29 group for self-perception, role-emotional, and acne symptoms (Figure 3)

Across Age Groups

 ◾ Reductions in inflammatory or noninflammatory lesion counts and the percent of 
participants with ≥2-grade EGSS reduction were generally greater in the 20-29 and 30+ 
age groups compared with the 13-19 age group, although these differences were not 
statistically significant (Figures 1 and 2)

 ◾ The greatest improvements in QoL domains occurred in the 20-29 and 30+ groups 
compared with the 13-19 group; these differences did not reach statistical significance 
(Figure 3) 

FIGURE 1. LS Mean Percent Reduction from Baseline in Inflammatory (A) and 
Noninflammatory (B) Lesion Counts by Age Group and Visit 
(ITT Population, Pooled)

#(

-70%

-50%

-30%

-10%

-30.5%

Week 4
LS

 M
e
a
n
 P

e
rc

e
n
t 

C
h
a
n
g

e
 

F
ro

m
 B

a
se

lin
e

A. In�ammatory Lesions

-27.4%

-28.1%

-24.1%

-34.6%

-36.3%Vehicle:

-44.6%

Week 8
-37.9%

-46.7%

-36.4%

-50.3%

-49.7%

#(

-55.3%

Week 12
-45.2%

-55.8%

-46.6%

-63.5%

-56.7%

13-19 y (n=173)

20-29 y (n=163)

30+ y (n=80)

#(

-70%

-50%

-30%

-10%

-21.3%

Week 4

LS
 M

e
a
n
 P

e
rc

e
n
t 

C
h
a
n
g

e
 

F
ro

m
 B

a
se

lin
e

B. Nonin�ammatory Lesions

-17.0%

-25.6%

-18.2%

-27.6%

-20.3%Vehicle:

-36.0%

Week 8
-22.1%

-39.2%

-29.9%

-45.2%

-36.4%

#(

-47.1%

Week 12
-27.6%

-55.2%

-39.3%

-59.0%

-45.4%

13-19 y (n=173)

20-29 y (n=163)

30+ y (n=80)

*P<0.05 vs vehicle; **P<0.01 vs vehicle; ***P<0.001 vs vehicle. 
There were no significant differences across the 3 age groups at weeks 4, 8, or 12.   
Vehicle: 13-19 y (n=184); 20-29 y (n=189); 30+ y (n=76). 
Multiple imputation method used for missing values. ITT, intent-to-treat; LS, least squares. 

 ◾ Age-related trends were observed with hyperpigmentation, in which older females had 
higher mean baseline values; however, mean ratings were still below mild (1) at baseline 
and did not increase by week 12

FIGURE 4. Mean Cutaneous Safety and Tolerability Scores in Tretinoin-Treated 
Females by Age Group and Visit (Safety Population, Pooled)

0

1

Scaling

M
e
a
n
 S

co
re

Severe3

Age 13-19 at Baseline

Age 13-19 at Week 12

2

Erythema Itching Burning

Moderate

Mild

Stinging Hypopigmentation Hyperpigmentation

Age 20-29 at Baseline

Age 20-29 at Week 12

Age 30+ at Baseline

Age 30+ at Week 12

No imputation for missing values. Scores were rated from 0 (none) to 3 (severe).

CONCLUSIONS
 ◾ In adult and adolescent females with moderate-to-severe acne, tretinoin 
0.05% lotion was effective versus vehicle in reducing noninflammatory 
lesions at week 12; in addition, tretinoin lotion significantly reduced 
inflammatory lesions in adolescents at week 12 

 ◾ Reductions in acne lesions/EGSS scores and improvements in QoL 
domains were generally greater in the older age groups (20-29 and 
30+ years) compared with younger females (13-19 years), although these 
differences did not reach statistical significance

 ◾ Tretinoin 0.05% lotion was well tolerated by all age groups

REFERENCES
1. Zaenglein AL, et al. J Am Acad Dermatol. 2016;74(5):945-973.e933.
2. Skroza N, et al. J Clin Aesthet Dermatol. 2018;11(1):21-25.
3. Collier CN, et al. J Am Acad Dermatol. 2008;58(1):56-59.
4. Tan JK, et al. J Cutan Med Surg. 2008;12(5):235-242.
5. Tyring SK, et al. J Drugs Dermatol. 2018;17(10):1084-1091.

AUTHOR DISCLOSURES
Dr. Linda Stein Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO, Dermavant, Incyte, Novartis, 
AbbVie, and Lilly. Dr. David Pariser has served as consultant to Atacama Therapeutics, Bickel Biotechnology, Biofrontera AG, 
Celgene, Dermira, LEO, Regeneron, Sanofi, TDM SurgiTech, TheraVida, and Ortho Dermatologics; investigator for Abbott 
Laboratories, Almirall, Amgen, AOBiome, Asana Biosciences, Bickel Biotechnology, Celgene, Dermavant, Dermira, Eli Lilly, LEO, 
Menlo Therapeutics, Merck & Co., Novartis, Novo Nordisk A/S, Ortho Dermatologics, Pfizer, Regeneron, and Stiefel; on advisory 
board for Pfizer; and on the data monitoring board for BMS. Dr. Eric Guenin is an employee of Ortho Dermatologics and may hold 
stock and/or stock options in its parent company.

Linda Stein Gold, MD1; David M Pariser, MD2; Eric Guenin, PharmD, PhD, MPH3
1Henry Ford Hospital, Detroit, MI; 2Virginia Clinical Research Center, Norfolk, VA; 3Ortho Dermatologics*, Bridgewater, NJ
*Ortho Dermatologics is a division of Bausch Health US, LLC.