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 common problem among Asian adolescents and adults1

 ◾ Generally, Asian skin is more pigmented than white people of European descent, and Asians have 
a high risk of acne sequelae such as post-inflammatory hyperpigmentation1

 ◾ The first tretinoin lotion 0.05% formulation was developed by utilizing novel polymeric emulsion 
technology to provide an alternative, lower-dose tretinoin option for patients who may be 
sensitive to the irritant effects of other tretinoin formulations2

 ◾ Tretinoin 0.05% lotion was efficacious and well tolerated in two phase 3 studies of participants ≥9 
years of age with moderate-to-severe acne (NCT02932306, NCT02965456)3

OBJECTIVE

 ◾ To assess efficacy and safety of tretinoin 0.05% lotion in Asian participants with moderate-to-
severe acne and to place these data into context with the overall study population

METHODS

 ◾ In two phase 3, double-blind, vehicle-controlled 12-week studies, eligible participants aged 
≥9 years with moderate-to-severe acne were randomized (1:1) to receive once-daily 
tretinoin 0.05% lotion or vehicle 

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

 ◾ Data from these two studies were pooled and analyzed post hoc for Asian participants and the 
total population

 ◾ Efficacy assessments included reductions in noninflammatory/inflammatory lesion counts and 
treatment success, defined as percent of participants achieving ≥2-grade reduction in Evaluator’s 
Global Severity Score (EGSS) and a clear/almost clear score

 ◾ Adverse events (AEs) and cutaneous safety/tolerability were also assessed

RESULTS

Participants

 ◾ A total of 1,640 participants were included in the pooled intent-to-treat analysis, of whom 69 were 
Asian (mean age 20.9 years [range: 12–48 years]; 60.9% female)

Efficacy

 ◾ At week 12, least-squares mean percent reductions from baseline in inflammatory lesion counts 
were greater with tretinoin 0.05% lotion versus vehicle—slightly greater in magnitude than the 
overall population—but the difference was not significant in Asian participants (Figure 1A)

 ◾ Noninflammatory lesion count reductions were significantly greater with tretinoin 0.05% lotion 
versus vehicle in Asian participants and all participants (Figure 1B)

 ◾ Treatment success at week 12 was greater with tretinoin 0.05% lotion versus vehicle in Asians and 
all participants, though this difference was not significant in Asians (Figure 2)

Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in Asians 

FIGURE 2. Percentage of Asian and All Participants Achieving Treatment Successa 

at Week 12 (ITT Population, Pooled)

20%

25%

30%
27.2%

17.7%16.9%

9.3%

0

5%

10%

15%

35%

Asian Participants All Participants

P
e
rc

e
n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

36 33 819 821

Tretinoin 0.05% Lotion        Vehicle Lotion

n=

***P<0.001 vs vehicle.  
aDefined as ≥2-grade reduction from baseline in Evaluator’s Global Severity Score with a final grade of 0 (clear) or 1 (almost clear). 
Multiple imputation method used for missing values. ITT, intent-to-treat.

 

FIGURE 3. Cutaneous Safety and Tolerability in Asian and All Participants Treated 

with Tretinoin 0.05% Lotion (Safety Population, Pooled)

0

1

2

3

M
e
a
n
 S

co
re

Baseline Week 4 Week 8 Week 12

Scaling (Asian)
Erythema (Asian)
Scaling (All)
Erythema (All)

0

1

2

3

Baseline Week 4 Week 8 Week 12

Itching (Asian)
Burning (Asian)

Burning (All)
Stinging (All)

0

1

2

3

Baseline Week 4 Week 8 Week 12

Hypopigmentation (Asian)
Hyperpigmentation (Asian)
Hypopigmentation (All)
Hyperpigmentation (All)

Stinging (Asian)
Itching (All)

No imputation for missing values.

FIGURE 1. Mean Percent Reduction from Baseline in Inflammatory (A) 
and Noninflammatory (B) Lesion Counts in Asian and All Participants 
(ITT Population, Pooled)

-22.0%

-44.4%

-58.6%

-24.1%
-35.0%

-41.5%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

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

Asian Participants

Tretinoin 0.05% Lotion (n=36)
Vehicle Lotion (n=33)

Baseline Week 4 Week 8 Week 12

A. In�ammatory Lesions

-27.9%

-40.7%

-52.1%

-24.7%

-33.2%
-41.0%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

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

All Participants

Tretinoin 0.05% Lotion (n=819)
Vehicle Lotion (n=821)

Baseline Week 4 Week 8 Week 12

-24.5%

-34.5%

-51.4%

-6.6%
-9.4%

-23.9%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

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

Asian Participants

Tretinoin 0.05% Lotion (n=36)
Vehicle Lotion (n=33)

Baseline Week 4 Week 8 Week 12

B. Nonin�ammatory Lesions

-22.7%

-34.9%

-46.1%

-15.8%

-23.7%
-29.9%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

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

All Participants

Tretinoin 0.05% Lotion (n=819)
Vehicle Lotion (n=821)

Baseline Week 4 Week 8 Week 12

*P<0.05 vs vehicle; ***P<0.001 vs vehicle.  
Multiple imputation method used for missing values. 
ITT, intent-to-treat; LS, least squares. 

Safety

 ◾ In tretinoin-treated participants, treatment-emergent AEs (TEAEs) were reported in 14.7% of Asian 
and 23.5% of all participants (Table 1)

• In Asian participants, all TEAEs were mild or moderate and none were related to treatment

 ◾ Slight transient increases occurred over the first 4-8 weeks in scaling, burning, and stinging (all and 
Asian) and itching (Asian); most scores were generally similar to baseline by week 12 (Figure 3)

• Mild hyperpigmentation was reported at baseline for Asian participants (mean score 0.7) and 
remained mild throughout the study (0.6-0.7)

TABLE 1.  Adverse Events (Safety Population, Pooled)

Asian Participants All Participants

Tretinoin 0.05% 
(n=34)

Vehicle  
(n=31)

Tretinoin 0.05% 
(n=767)

Vehicle  
(n=783)

Summary of AEs, n (%)

 Any AE 5 (14.7) 6 (19.4) 180 (23.5) 151 (19.3)

 Any serious AEa 0 0 7 (0.9) 4 (0.5)

Severity of AEs, n (%)

 Mild 3 (8.8) 5 (16.1) 105 (13.7) 95 (12.1)

 Moderate 2 (5.9) 1 (3.2) 67 (8.7) 46 (5.9)

 Severe 0 0 8 (1.0) 10 (1.3)

Relationship to study drug, n (%)

 Relatedb 0 1 (3.2) 62 (8.1) 15 (1.9)

 Unrelated 5 (14.7) 5 (16.1) 118 (15.4) 136 (17.4)
aNo serious AEs were considered related to treatment. 
bAll related treatment-emergent AEs were classified as general disorders and administration site conditions. 
AE, adverse event.

CONCLUSIONS
 ◾ Data pooled from two phase 3 studies showed that treatment with 
tretinoin 0.05% lotion provided statistically greater reductions in 
noninflammatory lesion counts versus vehicle in Asian participants, similar 
to the overall study population

 ◾ The lack of statistical significance versus vehicle for inflammatory lesions 
and treatment success in Asian participants may be due to the small 
number (n=69) in this analysis, as mean values for these efficacy 
assessments were similar to or greater than the overall study population

 ◾ Tretinoin 0.05% lotion was well tolerated in Asian and all participants, with 
mean cutaneous safety and tolerability ratings between none and mild, 
including hyperpigmentation

REFERENCES
1. See JA, et al. J Dermatol. 2018;45(5):522-528.
2. Kircik LH, et al. J Drugs Dermatol. 2019;18(4):s148-154.
3. Tyring SK, et al. J Drugs Dermatol. 2018;17(10):1084-1091.

AUTHOR DISCLOSURES
Dr. George Han has nothing to disclose. Dr. April Armstrong has served as a research investigator and/or 
consultant for AbbVie, Janssen, Leo, Novartis, UCB, Ortho Dermatologics, Dermira, Sanofi, Regeneron, BMS, 
Dermavant, and Modernizing Medicine. Dr. Seemal Desai has served as a research investigator and/or consultant 
for Skinmedica, Ortho Dermatologics, Galderma, Pfizer, Dermavant, Almirall, Dermira, and Watson. Dr. Eric 
Guenin is an employee of Ortho Dermatologics and may hold stock or stock options in its parent company.

George Han, MD, PhD1; April W Armstrong, MD, MPH2; Seemal R Desai, MD3,4; Eric Guenin, PharmD, PhD, MPH5
1Icahn School of Medicine at Mount Sinai, New York, NY; 2Keck School of Medicine at University of Southern California, Los Angeles, CA; 3Innovative Dermatology, PA, Plano, TX; 4The University of Texas Southwestern Medical Center, Dallas, TX; 5Ortho Dermatologics*, Bridgewater, NJ
*Ortho Dermatologics is a division of Bausch Health US, LLC.