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 the most common dermatologic issue in 
patients with skin of color1

 ◾ Additionally, the prevalence of acne in adults is 
increasing, and it occurs more often in adult females 
than males2,3

 ◾ 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)4 

OBJECTIVE

 ◾ To assess efficacy of this novel tretinoin 0.05% lotion in 
participants by gender as well as black and white race 
(self-identified)

METHODS

 ◾ In two phase 3, randomized, multicenter, double-blind, 
parallel-group, vehicle-controlled studies, participants 
with moderate-to-severe acne were equally randomized 
to tretinoin 0.05% lotion or vehicle lotion once daily for 
12 weeks

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

 ◾ A pooled post hoc analysis was conducted to evaluate 
the effect of gender and race on the efficacy of tretinoin 
0.05% lotion

 ◾ Efficacy assessments included change from baseline  
in inflammatory/noninflammatory lesion counts and 
percentage of participants achieving treatment  
success, defined as ≥2-grade reduction in the  
Evaluator Global Severity Score (EGSS) and a clear/
almost clear score

Efficacy of a Novel Tretinoin 0.05% Lotion in the Treatment of Moderate-to-Severe Acne by Gender and Race:  
Pooled Analysis of Two Phase 3 Studies

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

-30.2%

-46.1%

-56.9%

-27.1%

-38.7%

-47.1%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

LS
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e
a
n
 P

e
rc

e
n
t 

C
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a
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e
 

F
ro

m
 B

a
se

lin
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Females

Tretinoin 0.05% Lotion (n=433)
Vehicle Lotion (n=476)

Baseline Week 4 Week 8 Week 12

A. In�ammatory Lesions

B. Nonin�ammatory Lesions

-26.0%

-39.2%

-53.4%

-21.8%

-30.2%

-39.4%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

LS
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e
a
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C
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a
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F
ro

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 B

a
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lin
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Males
Baseline Week 4 Week 8 Week 12

Tretinoin 0.05% Lotion (n=386)
Vehicle Lotion (n=345)

-24.1%

-38.2%

-51.7%

-17.1%

-27.5%
-34.9%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

LS
 M

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a
n
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C
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a
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F
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a
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lin
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Females

Tretinoin 0.05% Lotion (n=433)
Vehicle Lotion (n=476)

Baseline Week 4 Week 8 Week 12

-22.9%

-34.9%

-46.1%

-15.6%

-22.7%

-29.7%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

LS
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a
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C
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F
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Males
Baseline Week 4 Week 8 Week 12

Tretinoin 0.05% Lotion (n=386)
Vehicle Lotion (n=345)

0%

**P<0.01 vs vehicle; ***P≤0.001 vs vehicle.  
Multiple imputation method used for missing values. 
ITT, intent-to-treat; LS, least squares. 

FIGURE 2. Percentage of Participants Achieving Treatment Successa at Week 12 by Gender and Race 
(ITT Population, Pooled)

23.6%

13.5%

35%

All

P
e
rc

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n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

433 476

Tretinoin 0.05% Lotion Vehicle Lotion Tretinoin 0.05% Lotion Vehicle Lotion

30%

25%

20%

15%

10%

5%

0%

23.3%

12.6%

White
286 336

23.0%

15.1%

Black
111 98

Females

16.1%

7.6%

35%

All

P
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rc

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n
ta

g
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f 
P

a
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ic
ip

a
n
ts

386 345

30%

25%

20%

15%

10%

5%

0%

15.4%

7.7%

White
307 283

18.0%

10.2%

Black
54 45

Males

n= n=

**P<0.01 vs vehicle; ***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.

RESULTS

Participants

 ◾ A total of 1,640 participants were included in the 
pooled analysis

• Females (tretinoin, n=433; vehicle, n=476): white 
females (tretinoin, n=286; vehicle, n=336); black 
females (tretinoin, n=111; vehicle, n=98)

• Males (tretinoin, n=386; vehicle, n=345): white males 
(tretinoin, n=307; vehicle, n=283); black males 
(tretinoin, n=54; vehicle, n=45)

 ◾ Mean age was slightly higher for females than males 
(mean age [standard deviation]):

• Females (22.4 years [8.2]): white females (22.0 [7.9]); 
black females (23.6 [8.7]) 

• Males (18.1 years [5.2]): white males (18.0 [4.9]); black 
males (18.8 [6.4])

Efficacy

Females and Males: Overall
 ◾ At week 12, all tretinoin-treated females and males had 
significantly greater mean percent reduction from 
baseline versus vehicle in inflammatory (Figure 1A) and 
noninflammatory lesion counts (Figure 1B) and a larger 
percentage achieved treatment success versus vehicle 
(Figure 2)

 ◾ Compared with males, tretinoin-treated females had 
greater mean percent reductions in noninflammatory 
lesion counts at week 12 (51.7% vs 46.1%; P<0.05) and 
a larger percentage achieved treatment success 
(23.6% vs 16.1%; P<0.05)

Females and Males: By Race
 ◾ At week 12, there were significant reductions in 
inflammatory and noninflammatory lesion counts with 
tretinoin treatment versus vehicle in white females, 
white males, and black males (Figures 3A and 3B)

 ◾ Compared with vehicle, significantly more 
tretinoin-treated white females and males achieved 
treatment success at week 12 (Figure 2)

 ◾ The percentages of tretinoin-treated black males and 
females achieving treatment success were greater than 
vehicle, but these differences were not significant 
(Figure 2)

Edward Lain, MD, MBA1; Doris Day, MD2; Julie C Harper, MD3; Eric Guenin, PharmD, PhD, MPH4
1Austin Institute for Clinical Research, Austin, TX; 2Day Dermatology and Aesthetics, New York, NY; 3Dermatology and Skin Care Center of Birmingham, Birmingham, AL; 4Ortho Dermatologics*, Bridgewater, NJ
*Ortho Dermatologics is a division of Bausch Health US, LLC.

FIGURE 3. Mean Percent Reduction from Baseline in Inflammatory (A) and Noninflammatory (B) Lesion Counts 
by Gender, Race, and Visit (ITT Population, Pooled)

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

LS
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F
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Females

Tretinoin: Black Females (n=111)
Vehicle: Black Females (n=98)

Baseline Week 4 Week 8 Week 12

A. In�ammatory Lesions

B. Nonin�ammatory Lesions

Tretinoin: White Females (n=286)
Vehicle: White Females (n=336)

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

LS
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C
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F
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Females

Tretinoin: Black Females (n=111)
Vehicle: Black Females (n=98)

Baseline Week 4 Week 8 Week 12

Tretinoin: White Females (n=286)
Vehicle: White Females (n=336)

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

LS
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Males

Tretinoin: Black Males (n=54)
Vehicle: Black Males (n=45)

Baseline Week 4 Week 8 Week 12

Tretinoin: White Males (n=307)
Vehicle: White Males (n=283)

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

LS
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Males

Tretinoin: Black Males (n=54)
Vehicle: Black Males (n=45)

Baseline Week 4 Week 8 Week 12

Tretinoin: White Males (n=307)
Vehicle: White Males (n=283)

#

##

##

##

White participants: *P<0.05 vs vehicle; **P<0.01 vs vehicle; ***P≤0.001 vs vehicle. 
Black participants:  #P<0.05 vs vehicle; ##P<0.01 vs vehicle. 
Multiple imputation method used for missing values. 
ITT, intent-to-treat; LS, least squares. 

CONCLUSIONS
 ◾ Tretinoin 0.05% lotion was significantly more effective than vehicle in reducing inflammatory and 
noninflammatory acne lesions and producing treatment success in males and females with 
moderate-to-severe acne

 ◾ Tretinoin 0.05% lotion was also significantly more effective than vehicle in reducing inflammatory and 
noninflammatory acne lesions in white males and females and black males

 ◾ In black females, there were improvements in lesion count reductions and a greater percentage achieved 
treatment success with tretinoin 0.05% lotion, but no efficacy endpoints reached statistical significance 
versus vehicle; this may be due in part to the small sample size and/or the greater response to vehicle

REFERENCES
1. Alexis AF. J Drugs Dermatol. 2014;13(6):s61-65.
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. Tyring SK, et al. J Drugs Dermatol. 2018;17(10):1084-1091.

AUTHOR DISCLOSURES
Dr. Edward Lain has nothing to disclose. Dr. Doris Day has participated in speaker programs for Bausch Health. Dr. Julie Harper has received honoraria from Aclaris, Almirall, 
BioPharmX, Cassiopea, Cutanea, Dermira, Foamix, Galderma, LaRoche-Posay, Ortho Dermatologics, and Sun. Dr. Eric Guenin is an employee of Ortho Dermatologics and may 
hold stock and/or stock options in its parent company.