ACKNOWLEDGEMENTS: Medical writing support was provided by Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics | Presented at the Fall Clinical Dermatology Conference • October 17-20, 2019 • Las Vegas, NV

SYNOPSIS
 ◾ Quality of life (QoL) in patients with acne has been shown to correlate more strongly with patient-reported severity than 
physician-reported severity, suggesting that patient perception may be important to consider during acne treatment1

 ◾ Compared with other dermatologic conditions, acne is associated with greater negative psychosocial impacts, particularly with 
feelings of despair and distress2

 ◾ Acne-related QoL has been shown to be worse in women, possibly because of differences in perceptions regarding 
self-appearance and cosmetic concerns2 

 ◾ The first lotion formulation of tretinoin, developed by utilizing novel polymeric emulsion technology,3 has been evaluated in two 
phase 3 studies that included male and female patients with moderate-to-severe acne (NCT02932306, NCT02965456)4

OBJECTIVE
 ◾ To determine potential improvements in QoL with tretinoin 0.05% lotion and assess potential gender differences in these 
outcomes in a post hoc analysis of the pooled data from these two phase 3 studies

METHODS
 ◾ Data were pooled from two multicenter, randomized, double-blind, vehicle-controlled studies in which participants were 
randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks

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

 ◾ QoL was assessed using the validated Acne-QoL questionnaire in 4 different domains (self-perception, role-emotional, 
role-social, acne symptoms)

 ◾ In addition, participants completed a Patient Satisfaction Survey (PSS) at baseline and Week 12 to assess satisfaction with 
previous acne therapy using a 10-point scale, where 10=most satisfied

RESULTS
 ◾ The pooled population included 1640 participants (tretinoin, n=819; vehicle, n=821), 909 (55.4%) of whom were female; 
participants’ ages ranged from 9 to 58 years

 ◾ Mean PSS scores at baseline were 4.7 and 4.6 for tretinoin 0.05% lotion and vehicle, respectively, indicating similar satisfaction 
with prior acne treatment

• At Week 12, satisfaction was significantly greater with tretinoin 0.05% lotion vs vehicle (7.2 vs 6.6, P<0.001)

 ◾ Acne-QoL scores at baseline indicated impairment in all domains (Figure 1), with lower (worse) mean scores in female 
participants as follows: self-perception (2.6 vs 3.5 for males); role-emotional (2.6 vs 3.4); role-social (3.5 vs 4.1); acne symptoms 
(2.7 vs 3.2; Figure 2)

• Mean scores for all domains increased (improved) significantly by Week 12 (P<0.001) in the overall population 

• While domain scores in the male participants remained significantly greater compared to those in female participants, changes 
from baseline in the female participants were much greater (Figures 2 and 3)

• At Week 12, mean scores for self-perception, role-emotional, role-social and acne symptoms were 4.3 (65% improvement), 
4.2 (62%), 4.8 (37%), and 4.1 (52%) in females, compared to 4.8 (37%), 4.6 (35%), 5.2 (27%), and 4.4 (38%) in males (Figure 3)

Acne-Related Quality of Life: Efficacy of a Novel Tretinoin 0.05% Lotion  
in Male and Female Patients with Moderate-to-Severe Disease

Sharleen St. Surin-Lord, MD1,2; William Philip Werschler, MD3; Eric Guenin, PharmD, PhD, MPH4
1Visage Dermatology and Aesthetic Center, Visage Clinical Research, Largo, MD; 2Howard University College of Medicine, Washington, DC; 3University of Washington, School of Medicine, Seattle, WA; 4Ortho Dermatologics, Bridgewater, NJ

FIGURE 1: Average Acne-QoL Domain Scores at Baseline for all Participants in the Tretinoin 0.05% Lotion or Vehicle 
Treatment Groups (ITT Population; Pooled Data)

2.75

5.00

4.75

4.50

4.25

4.00

3.75

3.50

3.25

3.00

5.25

M
e
a
n
 S

co
re

 (
9
5
%

 C
I)

Acne Quality of Life Domains

Tretinoin Lotion

Vehicle Lotion

Self-Perception Role-Emotional Role-Social Acne Symptoms

  
Acne-QoL, Acne-Specific Quality of Life Questionnaire; ITT, intent-to-treat.

FIGURE 2: Average Acne-QoL Domain Scores at Baseline for Males and Females in the Tretinoin 0.05% Lotion Group 
(ITT Population; Pooled Data)

2.25

5.00

4.75

4.50

4.25

4.00

3.75

3.50

3.25

3.00

2.75

2.50

5.50

5.25

M
e
a
n
 S

co
re

 (
9
5
%

 C
I)

Acne Quality of Life Domains

Male

Female

Self-Perception Role-Emotional Role-Social Acne Symptoms

  
Acne-QoL, Acne-Specific Quality of Life Questionnaire; ITT, intent-to-treat.

FIGURE 3:  Average Acne-QoL Domain Scores at Week 12 for Males and Females in the Tretinoin 0.05% Lotion Group 
(ITT Population; Pooled Data) 

2.25

5.00

4.75

4.50

4.25

4.00

3.75

3.50

3.25

3.00

2.75

2.50

5.50

5.25

M
e
a
n
 S

co
re

 (
9

5
%

 C
I)

Acne Quality of Life Domains

Male

Female

Self-Perception Role-Emotional Role-Social Acne Symptoms

 Acne-QoL, Acne-Specific Quality of Life Questionnaire; ITT, intent-to-treat.

CONCLUSION
 ◾ Tretinoin 0.05% lotion was significantly more effective than its vehicle in achieving 
improvements in QoL, especially in female participants

 ◾ Improvements seen in each QoL domain were mirrored by a significant improvement in 
participant satisfaction  

REFERENCES
1. Martin AR, et al. Clin Exp Dermatol. 2001;26(5):380-385.
2. Gorelick J, et al. J Dermatol Nurses Assoc. 2015;7(3):154-162.

3. Kircik LH, et al. J Drugs Dermatol. 2019;18(4):s148-154.
4. Tyring SK, et al. J Drugs Dermatol. 2018;17(10):1084-1091.

AUTHOR DISCLOSURES
Dr. Sharleen St. Surin-Lord is a paid Speaker for Galderma and Pfizer, and a paid consultant for Bausch Health. 

Dr. William Philip Werschler has served as an investigator for Ortho Dermatologics.

Dr. Eric Guenin is an employee of Ortho Dermatologics.