THERAPEUTICS FOR THE CLINICIAN

opyTolerability of Tretinoin Lotion 0.05%
for Moderate to Severe Acne
Vulgaris: A Post Hoc Analysis in a
Black Population

PRACTICE POINTS

•

D

o

•

 cne vulgaris is the most common dermatologicA
disorder seen in black patients, though data on treatment effects is lacking.
Postinflammatory hyperpigmentation (PIH) frequently
coexists with acne, and retinoids are known totreat both.
Tretinoin lotion 0.05% is effective in treating both inflammatory and noninflammatory lesions in black patientswith acne and reducing PIH without the irritant contact
dermatitis seen with other retinoid formulations.

both the likelihood of seeing a dermatologist and being
treated.3 Black patients are less likely to visit a dermatologist or receive any acne medication. Acne in black skin isfrequently associated with postinflammatory hyperpigmentation (PIH), an important consideration in treatment
choice and maintenance.
There is a paucity of clinical studies that specifically evaluate acne treatment in this patient population. An 8-week,
vehicle-controlled study with tretinoin cream 0.025%
in 27 black patients with acne reported notable decreases
in papules, pustules, and hyperpigmented macules in
83% of patients treated with tretinoin compared toonly 13% receiving vehicle.4 However, irritation andinflammation were problematic. An open-label studyof adapalene gel 0.1% in 65 black South Africans also
demonstrated significant improvement in inflammatory and noninflammatory lesions and PIH (P<.01),
with seemingly better tolerability.5,6 A meta-analysis of
5 randomized studies from the United States and Europe(N=655) compared the efficacy and safety of adapalene
gel 0.1% in black (n=46) and white patients.7 There wasno significant difference in percentage reduction in comedonal (44%) or total (42%) lesion counts. The percentage
reduction in inflammatory lesion counts (53%) was significantly greater in black patients (P=.012). Tolerability
also was better; black patients experienced significantly
less erythema and scaling (P<.001 and P=.026, respectively), though erythema can be underestimated in darker
skin tones because of the masking effects of melanin.5,7Dryness was more common, though a smaller percentage

no

•

tc

Neal D. Bhatia, MD; William P. Werschler, MD; Fran E. Cook-Bolden, MD;
Eric Guenin, PharmD, PhD, MPH

CU

TI
S

Acne vulgaris (acne) is the most common dermatologic disorder seen inblack patients. However, data are lacking on the effects of treatments,
such as topical retinoids. Acne in black patients is frequently associated with postinflammatory hyperpigmentation (PIH), which can be ofgreater concern than the patient’s acne and often is the main reason
these patients seek a dermatologist consultation. Retinoids can treat
both acne and PIH. However, the potential for retinoids to induce anirritant contact dermatitis, which could lead to PIH, is a concern. A lotion
formulation of tretinoin was developed to provide an important alternative option to treat acne in black patients who may be sensitive to theirritant effects of other tretinoin formulations or where PIH is a concern.
Cutis. 2020;106:45-50.

A

cne vulgaris (acne) is the most common dermatologic condition in black patients.1,2 However,among outpatient visits, racial disparities exist in

Dr. Bhatia is from Therapeutics Clinical Research, San Diego, California. Dr. Werschler is from Spokane Dermatology Clinic, Washington.
Dr. Cook-Bolden is from Mount Sinai Health Systems, New York, New York. Dr. Guenin is from Ortho Dermatologics, Bridgewater, New Jersey.
Dr. Bhatia is a consultant for Ortho Dermatologics. Dr. Werschler is on the advisory board for and has received clinical trials support from Ortho
Dermatologics. Dr. Cook-Bolden is a speaker for Ortho Dermatologics. Dr. Guenin is an employee of Ortho Dermatologics and holds an equity
position in Bausch Health.
The eTable is available in the Appendix online at www.mdedge.com/dermatology.
Correspondence: Neal D. Bhatia, MD, Therapeutics Clinical Research, 9025 Balboa Ave, San Diego, CA 92123 (dsbconsulting37@gmail.com).

WWW.MDEDGE.COM/DERMATOLOGY

VOL. 106 NO. 1

I JULY 2020 45

Copyright Cutis 2020. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher.

THERAPEUTICS FOR THE CLINICIAN

period of up to 1 month was required for patients
who previously used prescription and over-thecounter acne treatments, and a washout period of
6 months was required for systemic retinoids.

Safety Evaluation

tc

op

y

Cutaneous safety (erythema and scaling) and tolerability (itching, burning, and stinging) were evaluated on a
4-point scale (0=none; 3=severe). Severity of hypopigmentation and hyperpigmentation also was assessedusing this 4-point scale. The investigator assessed
erythema and scaling at the time of each study visit.
Reports of itching, burning, and stinging were solicitedfrom participants and recorded as an average score of
their symptoms during the period since the prior visit.
Adverse events were evaluated throughout andsummarized by treatment group, severity, and relationship to study medication.

Statistical Analysis

The safety analysis set comprised all randomized patients
who were presumed to have used the study drug at least
once and who provided at least 1 postbaseline evaluation. All AEs occurring during the studies were recorded
and coded using the Medical Dictionary for Regulatory
Activities version 18.0. Treatment group comparisonswere made by tabulating the frequency of participants
reporting 1 or more AEs during the study.
Cutaneous safety (scaling, erythema, hypopigmentation, and hyperpigmentation) and tolerability (itching,burning, and stinging) scores were presented by treatment group with descriptive statistics at baseline andweeks 4, 8, and 12. Frequencies and percentages for eachoutcome category were included in the statistics.

METHODS
Study Design

D

o

no

of black patients reported moderate or severe dryness
compared to white patients (7% vs 18%).7
Black patients also are less likely to receive combination therapy, and again clinical data are limited.3
A more recent subgroup analysis evaluated the safety
and efficacy of adapalene 0.1%–benzoyl peroxide 2.5%
gel in black patients with moderate acne from 3 studies(n=238 out of a total of 3855 patients).8 Similar results
were obtained as in the overall study populations, with
64.3% and 48.5% reductions in inflammatory and noninflammatory lesion counts, respectively, at week 12.
The most common treatment-related adverse event(AE) in both treatment groups was dry skin (11.3%).8
Extensive clinical data in a predominantly white
population have shown that topical retinoids (eg, tretinoin, adapalene, tazarotene) are highly effective intreating acne, and they are recommended as the cornerstone of topical therapy.9 However, there is a common perception that they are primarily effective in
comedonal acne10 and that their use is associated withnotable cutaneous irritation.11,12 Several attempts havebeen made to alleviate the tolerability issue using novel
delivery systems. A new lotion formulation of tretinoin
recently was developed and leveraged polymeric emulsion technology with the aim to improve both efficacy
and tolerability of tretinoin. Herein, we performed apost hoc analysis of 2 large phase 3 clinical studies13 inpatients with moderate or severe acne treated with tretinoin lotion 0.05% to evaluate its safety and tolerability
in a black population.

CU

TI
S

We conducted a post hoc analysis of 2 identical multicenter, randomized, double-blind, vehicle-controlled,parallel-group clinical studies13 in black patients withmoderate or severe acne. Protocols received approval
from the appropriate institutional review board foreach center before patient enrollment, and the studies
were conducted in accordance with the Declaration of
Helsinki and Good Clinical Practice as well as in compliance with local regulatory requirements. All patientswere informed of the study details and provided writtenconsent before entering the studies.
Patients were enrolled with an evaluator global
severity score (EGSS) of 3 (moderate) or 4 (severe).
Participants were randomized (1:1) to receive tretinoin
lotion 0.05% or vehicle applied to the face once dailyfor 12 weeks.

Study Population
Eligible patients for the post hoc analysis included
male and female patients with black skin who were
9 years and older and presented with 20 to 40 inflammatory lesions (papules, pustules, and nodules), 20
to 100 noninflammatory lesions (open and closed
comedones), and 2 or fewer nodules. A washout
46 I CUTIS®

RESULTS
Baseline Characteristics
A total of 308 patients were included in the post hoc
analysis. Overall, 257 (83.4%) patients completed thestudies, including 138 (83.6%) patients receiving tretinoin lotion 0.05% and 119 (83.2%) receiving vehicle(Figure 1). Completion rates were similar in the female
and male subgroups (83.3% and 83.8%, respectively). The
most common reasons for study discontinuations werelost to follow-up (n=32; 10.4%) or participant request(n=13; 4.2%) and were similar irrespective of treatment
or sex. There were no study discontinuations due to AEs.
Demographic data (Table) were similar across the2 treatment arms. The mean age (standard deviation [SD]) of the participants was 22.1 (8.35) years(range, 9–58 years). Participants were predominantly
female (209/308 [67.9%]) and tended to be a little older
than the males (mean age, 23.6 vs 18.8 years).
There were no noticeable differences between treatment groups regarding baseline lesion counts or EGSS.
At baseline, the mean number (SD) of inflammatory andnoninflammatory lesions was 25.2 (4.87) and 41.1 (16.55),
WWW.MDEDGE.COM/DERMATOLOGY

Copyright Cutis 2020. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher.

FIGURE 1. Participant dispositionof black acne population showing
percentage completion and reasons for discontinuation (intentionto-treat population; pooled data;
N=308).

D

o

no

tc

op

y

THERAPEUTICS FOR THE CLINICIANTISDemographics and Baseline Characteristics for Black Acne Population Treated With
Tretinoin Lotion 0.05% or Vehicle (Intention-to-Treat Population; Pooled Data; N=308)
Tretinoin Lotion 0.05%(n=165)

Vehicle(n=143)Total(N=308)Mean age (SD), y

21.9 (7.96)

22.3 (8.81)

22.1 (8.35)

Age range, y

9–54

10–58

9–58

Male

54 (32.7)

45 (31.5)

99 (32.1)

Female111 (67.3)

98 (68.5)

209 (67.9)

Hispanic or Latino

63 (38.2)

49 (34.3)

112 (36.4)

Not Hispanic or Latino

102 (61.8)

94 (65.7)

196 (63.6)

3=moderate

160 (97.0)

126 (88.1)

286 (92.9)

4=severe5 (3.0)17 (11.9)

22 (7.1)

Mean inflammatory lesion count (SD)25.2 (4.89)

25.2 (4.87)

25.2 (4.87)

Mean noninflammatory lesion count (SD)40.8 (16.15)

41.5 (17.05)

41.1 (16.55)

CUSex, n (%)

Ethnicity, n (%)

Evaluator global severity score, n (%)

Abbreviation: SD, standard deviation.

WWW.MDEDGE.COM/DERMATOLOGY

VOL. 106 NO. 1

I JULY 2020 47

Copyright Cutis 2020. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher.

THERAPEUTICS FOR THE CLINICIAN

Safety

y

op

CU

TI
S

D

o

no

Treatment-Related AEs—More participants treated withtretinoin lotion 0.05% reported treatment-emergent AEs(TEAEs) compared to vehicle (35 vs 18). The majority ofparticipants reporting TEAEs were female (24 of 35). There
were 2 (1.3%) serious AEs with tretinoin lotion 0.05%(both female), and 1 female participant (0.6%) discontinued the study drug because of a TEAE (eTable).
Overall, there were 12 (7.7%) treatment-related AEs;
all were mild (n=10) or moderate (n=2). Treatmentrelated AEs reported by more than 1% of participants
treated with tretinoin lotion 0.05% included applicationsite pain (n=4; 2.6%), dryness (n=4; 2.6%), irritation(n=2; 1.3%), exfoliation (n=2; 1.3%), or erythema (n=2;1.3%). The majority of treatment-related AEs (10/12) werereported in the female subgroup. Although applicationsite pain (3.4%) and dryness (3.8%) were more commonly reported in the white population (unpublisheddata, Ortho Dermatologics) in the 2 studies, differences
between the 2 racial groups were not significant.
Cutaneous Safety and Tolerability—Erythema and scaling
were recorded by the investigator. Mild to moderate erythema was noted in 31% of participants at baseline, with
21% reporting mild to moderate scaling. Both improved
over the study period following treatment with tretinoin
lotion 0.05%, with 79% of participants having no erythemaand 88% having no scaling by week 12. Mean scores forerythema and scaling remained less than 0.5 throughout
the study (1=mild). There were slight transient increases
in the mean baseline score for scaling (from 0.2 to 0.3) atweek 4 in the active treatment group. By week 12, meanscores were half those reported at baseline (Figure 2).
Severity of itching, burning, and stinging was reported
by participants. Overall, 23% reported mild to moderateitching at baseline. Only 7 participants (5%) reported any
itching by week 12 in the tretinoin lotion 0.05% group.
Reports of burning and stinging were both rare and mild
at baseline. Mean scores for itching, burning, and stinging at baseline for those participants who were subsequently treated with tretinoin lotion 0.05% were 0.3, 0.1,
and 0.1, respectively (1=mild). Itching severity reduced
progressively with treatment. There were slight transient
increases in mean scores for burning (from 0.1 to 0.2) andstinging (from 0.1 to 0.2) at week 4, returning to baseline
levels or below by week 12.
Hyperpigmentation
andHypopigmentation—
There was a progressive improvement in baseline
hyperpigmentation severity in participants treated withtretinoin lotion 0.05%; mean scores reduced from
0.8 at baseline to 0.6 by week 12 (Figure 3), with asimilar improvement in both sexes (Figure 4). Moderatetcrespectively. At baseline, 286 (92.9%) participants had
moderate acne (EGSS=3). A higher proportion of maleparticipants (10.1%) had severe acne (EGSS=4) at baseline compared to female participants (5.7%).
At baseline, the mean score (SD) for scaling, erythema, itching, burning, and stinging in those participants that were subsequently treated with tretinoin
lotion 0.05% was 0.2 (0.42), 0.4 (0.68), 0.3 (0.60), 0.1 (0.28),
and 0.1 (0.32), respectively (where 1=mild)(Figure 2).
There were no differences in mean baseline scores
between active and vehicle treatment groups for hyperpigmentation (0.8 each) and hypopigmentation (0.1 each)in the active and vehicle treatment groups. Mean baseline
scores were slightly higher in the female participants (0.9)
compared to male participants (0.6). Baseline moderateor severe hyperpigmentation was reported in 23.2% and3.2% of participants, respectively, who were subsequently
treated with tretinoin lotion 0.05%, which also wasmore commonly reported in female participants (33/105[31.5%]) than male participants (8/50 [16.0%]).

A

B

FIGURE 2. A and B, Cutaneous safety and tolerability assessment from baseline to week 12 for black population treated with tretinoin
lotion 0.05% or vehicle (safety population; pooled data; N=291). Mean scores ranged from 0 to 3 (0=none; 1=mild).

48 I CUTIS®

WWW.MDEDGE.COM/DERMATOLOGY

Copyright Cutis 2020. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher.

THERAPEUTICS FOR THE CLINICIAN

y

CU

TI
S

D

o

no

Topical retinoids (eg, tretinoin, adapalene, tazarotene) arerecommended as the cornerstone of topical acne treatment,with safety and efficacy well documented in large pivotal
trials.14 However, data in black patients are lacking. Acne is
the most common dermatologic condition in these patients,
and yet investigation into this important population is limited to small study populations or subgroup analyses.
Tretinoin lotion 0.05% is a novel topical treatment formoderate to severe acne that leverages polymeric emulsion technology. The development rationale was to provide a tretinoin formulation with improved efficacy andtolerability, features that could be especially suited to black
patients with acne.
In our post hoc analysis of black patients with acne, tretinoin lotion 0.05% generally was considered safe and welltolerated. The most commonly reported treatment-related
AEs were of low incidence and included applicationsite reactions and skin-related events attributed to the
known properties of tretinoin. Most noteworthy was theextremely low irritation potential of this novel tretinoin
formulation. Treatment-related AEs generally were mild,
and interestingly, the majority occurred in female patients.
The incidence of the most common treatment-related
AEs—application-site dryness (2.6%) and application-site
pain (2.6%)—was lower than that reported in the white
populations in the 2 studies (3.8% and 3.4%, respectively).
(unpublished data, Ortho Dermatologics), though thedifferences were not significant (P=.625 and P=.799).

op

COMMENT

Approximately one-quarter of participants had mild
to moderate erythema, scaling, itching, and stinging atbaseline. All of these cutaneous symptoms improved withtreatment. There were slight transient increases in scaling
and stinging at week 4, with stinging more noticeable in
the female population. There were no noticeable changes
in mild to moderate burning during the study.
Postinflammatory hyperpigmentation is an importantconsideration in black patients with acne. It can arise fromeither acne-induced inflammation or injury. It can be ofgreater concern to the patient than the acne itself and often
is the main reason black patients seek a dermatologist
consultation. In a survey of adult female acne, nonwhite
women experienced substantially more PIH than white
women. In addition, clearance of PIH was most important
for these nonwhite women (42% vs 8% for white women),whereas lesion clearance was the most important aspect
for white women (58% vs 32% for nonwhite women).15
Erring on the side of increased tolerability is appropriate inblack patients with acne, given that any irritant reactions
can lead to pigmentary alterations—hyperpigmentation or
hypopigmentation—that can cause considerable patientanxiety. The psychologic impact of PIH can be devastating,and an ideal acne treatment in these patients would be
one that is effective against both PIH and acne. Tretinoin
cream 0.1% monotherapy has been shown to be effective
in reducing PIH.16 Postinflammatory hyperpigmentation
lesions and normal skin were assessed by clinical and colorimetric evaluations and by analysis of biopsy specimens.
Although facial PIH lesions in the 24 tretinoin-treatedpatients were significantly lighter after 40 weeks of treatment compared to vehicle in this study (P<.001), overall
improvement was first noted after 4 weeks (P=.009).
Normal skin also was minimally lightened by tretinoin;
however, exuberant local skin reactions, including peeling, developed in 50% of patients. Mild to moderate PIH
was present in the majority of tretinoin-treated patients atbaseline in our post hoc analysis, severe in 3.2% of cases,tc

to severe hyperpigmentation was reported in 24 (17.3%)
participants by week 12 compared to 41 (26.4%) atbaseline; the majority (n=21) were female at week 12.
Moderate to severe hyperpigmentation was reported in
24 (19.7%) participants treated with vehicle at week 12.
Hypopigmentation at baseline was rare and mild, andagain most common in female patients. There was noincrease in hypopigmentation over the course of the study.

FIGURE 3. Postinflammatory hyperpigmentation and hypopigmentation in black patients treated with tretinoin lotion 0.05% or vehicle frombaseline to week 12 (safety population; pooled data; N=291). Mean scores ranged from 0 to 3 (0=none; 1=mild).

WWW.MDEDGE.COM/DERMATOLOGY

VOL. 106 NO. 1

I JULY 2020 49

Copyright Cutis 2020. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher.

A

tc

op

y

THERAPEUTICS FOR THE CLINICIANB

FIGURE 4. A and B, Postinflammatory hyperpigmentation severity at baseline and week 12 by sex. Severity was determined using 4-point scaleno(0=none; 3=severe)(safety population; male and female subgroups; N=291).

TI
S

D

o

and both more common and severe in females. Meanscores reduced over the 12-week study period, from 0.6
to 0.4 in male patients and 0.9 to 0.7 in female patients.
Hypopigmentation was rare and mild at baseline and did
not increase over the course of the study. A pilot study
with a cream formulation of tazarotene in patients withacne from darker racial groups showed the retinoid to beeffective in treating PIH following 18 weeks of once-daily
application.17 Further longer-term studies on treating PIH
with tretinoin lotion 0.05% are warranted given its tolerability profile.

CONCLUSIONCUThis novel tretinoin lotion 0.05% formulation is a safe andwell-tolerated topical treatment for moderate to severe comedonal and inflammatory acne in black patients. Tretinoin
lotion 0.05% does not appear to induce PIH and may affordan effective, well-tolerated, dual-treatment option.
Acknowledgments—We thank Brian Bulley, MSc (Konic
Limited, United Kingdom), for medical writing support.
Ortho Dermatologics funded Konic’s activities pertaining
to this manuscript.

4.
5.
6.
7.

8.

9.

10.
11.

12.
13.

14.
15.

REFERENCES
1.

2.
3.

Halder RM, Grimes PE, McLaurin CI, et al. Incidence of common
dermatoses in a predominantly black dermatologic practice. Cutis.
1983;32:388,390.
Taylor SC, Cook-Bolden F, Rahman Z, et al. Acne vulgaris in skin ofcolor. J Am Acad Dermatol. 2002;46(suppl 2):S98-S106.
Rogers AT, Semenov YR, Kwatra SG, et al. Racial disparities in the management of acne: evidence from the National Ambulatory Medial Care
Survey, 2005-2014. J Dermatolog Treat. 2018;29:287-289.

50 I CUTIS®

16.

17.

Halder RM. The role of retinoids in the management of cutaneousconditions in blacks. J Am Acad Dermatol. 1998;39(suppl 2):S98-S103.
Jacyk WK. Adapalene in the treatment of African patients. J Eur Acad
Dermatol Venereol. 2001;15(suppl 3):37-42.
Jacyk WK, Mpofu P. Adapalene gel 0.1% for topical treatment of acne
vulgaris in African patients. Cutis. 2001;68(suppl 4):48-54.
Czernielewski J, Poncet M, Mizzi F. Efficacy and cutaneous safety ofadapalene in black patients versus white patients with acne vulgaris.
Cutis. 2002;70:243-248.
Alexis AF, Johnson LA, Kerrouche N, et al. A subgroup analysis to evaluate the efficacy and safety of adapalene-benzoyl peroxide topical gel inblack subjects with moderate acne. J Drugs Dermatol. 2014;13:170-174.
Leyden JJ, Shalita A, Thiboutot D, et al. Topical retinoids in inflammatory acne: a retrospective, investigator-blinded, vehicle-controlled,
photographic assessment. Clin Ther. 2005;27:216-224.
Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the
management of acne vulgaris. J Am Acad Dermatol. 2016;74:945-973.
Culp L, Moradi Tuchayi S, Alinia H, et al. Tolerability of topical retinoids:
are there clinically meaningful differences among topical retinoids?
J Cutan Med Surg. 2015;19:530-538.
Kircik LH. Evaluating tretinoin formulations in the treatment of acne.
J Drugs Dermatol. 2014;13:466-470.
Tyring SK, Kircik LH, Pariser DM, et al. Novel tretinoin 0.05% lotion forthe once-daily treatment of moderate-to-severe acne vulgaris: assessment of efficacy and safety in patients aged 9 years and older. J Drugs
Dermatol. 2018;17:1084-1091.
Leyden J, Stein-Gold l, Weiss J. Why topical retionoids are the mainstayof therapy for acne. Dermatol Ther (Heidelb) 2017;7:293-304.
Callender VD, Alexis AF, Daniels SR, et al. Racial differences in clinicalcharacteristics, perceptions and behaviors, and psychosocial impact ofadult female acne. J Clin Aesthet Dermatol. 2014;7:19-31.
Bulengo-Ransby SM, Griffiths CE, Kimbrough-Green CK, et al.
Topical tretinoin (retinoic acid) therapy for hyperpigmented lesions
caused by inflammation of the skin in black patients. N Engl J Med.
1993;328:1438-1443.
Grimes P, Callender V. Tazarotene cream for postinflammatory hyperpigmentation and acne vulgaris in darker skin: a double-blind, randomized, vehicle-controlled study. Cutis. 2006;77:45-50.

WWW.MDEDGE.COM/DERMATOLOGY

Copyright Cutis 2020. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher.

THERAPEUTICS FOR THE CLINICIANAPPENDIXeTABLE. Treatment-Emergent and Treatment-Related Adverse Events ThroughWeek 12 for Black Acne Population Treated With Tretinoin Lotion 0.05% or Vehicle(Pooled Data; Safety Population; N=291)
No. of Participants (%)
Vehicle Lotion (n=136)

Patients reporting any TEAE

35 (22.6)

18 (13.2)

Patients reporting any serious AE

2 (1.3)

Patients who died

0 (0)Patients who discontinued because of TEAE

1 (0.6)

op
0 (0)
0 (0)
0 (0)

25 (16.1)

Moderate

10 (6.5)

Severe0 (0)RelatedUnrelated
Treatment-related AEs reported by ≥1% of participants
Application-site painnoRelationship to study drug

3 (2.2)1 (0.7)

12 (7.7)

2 (1.5)16 (11.8)

4 (2.6)

1 (0.7)4 (2.6)0 (0)2 (1.3)1 (0.7)2 (1.3)0 (0)2 (1.3)

0 (0)

D

o

Application-site dryness

Application-site irritation

14 (10.3)

23 (14.8)

Application-site erythema
Application-site exfoliationtc

Severity of AEs reported
MildyTretinoin Lotion 0.05% (n=155)

CU

TI
S

Abbreviations: TEAE, treatment-emergent adverse event; AE, adverse event.

WWW.MDEDGE.COM/DERMATOLOGY

VOL. 106 NO. 1

I JULY 2020 E1

Copyright Cutis 2020. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher.