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 2023 • January 13-18, 2023 • Waimea, HI

SYNOPSIS 

 � Topical retinoids are a mainstay in the 
treatment of acne, but cutaneous 
irritation may limit their use and patient 
adherence

 � Tolerability of topical retinoids can be 
impacted by the retinoid itself, the 
concentration used, and the vehicle 
used for its delivery,1 as well as skin 
hydration

 � Newer, third- and fourth-generation 
topical retinoid formulations have been 
developed using lower concentrations, 
enhanced vehicles, and/or novel 
retinoids to be efficacious while 
providing a more patient-friendly 
tolerability profile2

 � Low-dose tazarotene 0.045% lotion was 
developed using polymeric emulsion 
technology to provide uniform and 
rapid distribution of tazarotene and 
hydrating ingredients on the skin in a 
highly spreadable formulation3

OBJECTIVES

 � To compare the tolerability of 
tazarotene 0.045% lotion with 
adapalene 0.3% gel and trifarotene 
0.005% cream 

METHODS

 � Healthy adults (≥18 years) with 
Fitzpatrick skin types I–II and normal 
upper back skin were enrolled in two 
identical 12-day modified cumulative 
irritation patch studies

 � In each study, two patches loaded with 
active ingredients and one control 
patch (no study product) were placed 
on participants’ upper back in a 
randomized, double-blind fashion 

 � In Study 1, active patches were loaded 
with 0.1 cc of adapalene 0.3% gel or 
tazarotene 0.045% lotion; in Study 2, 
active patches were loaded with 0.1 cc 
of trifarotene 0.005% cream or 
tazarotene 0.045% lotion (Figure 1)

• Patches were replaced every 2–3 
days, for a total of 5 applications

 � At each patch removal, Dermal Effects 
were assessed using an 8-point scale 
(0=no evidence of irritation; 7=strong 
reaction spreading beyond application 
site) and Other Effects were assessed 
using a 7-point scale (0=no other 
effects; 6=small petechial erosions  
and/or scabs)

• Assessments were analyzed using a 
Wilcoxon signed-rank test; group 
differences were considered 
significant at a P-value of ≤0.05

Comparison of Cutaneous Irritation With Repeated Application of Tazarotene 0.045% Lotion, Adapalene 0.3% Gel, 
and Trifarotene 0.005% Cream

Zoe D Draelos, MD1; Patricia Farris, MD2; Hilary Baldwin, MD3,4; Emil A Tanghetti, MD5
1Dermatology Consulting Services, High Point, NC; 2 Tulane University School of Medicine Department of Dermatology, New Orleans, LA; 3 The Acne Treatment and Research Center, Brooklyn, NY; 4Robert Wood Johnson University Hospital, New Brunswick, NJ; 5 Center for Dermatology and Laser Surgery, Sacramento, CA

RESULTS

Study 1: Adapalene 0.3% Gel vs Tazarotene 0.045% Lotion 
 � 20 White adults (22–69 years; 95% female) were enrolled and completed this study

 � Tazarotene 0.045% lotion and adapalene 0.3% gel were both assessed as mildly irritating, with 
Dermal Effects mean scores <1 (Figure 2)

• Differences in Dermal Effects mean scores between drugs were not statistically significant at 
any assessment, though there was slightly less irritation overall with tazarotene lotion than 
adapalene gel (highest mean scores: 0.50 and 0.80, respectively)

 � Other Effects mean scores were negligible (≤0.05) with both drugs

 � No irritation was observed at the control patch site at any study visit

FIGURE 2. Study 1: Irritation Potential of Adapalene 0.3% Gel vs 
Tazarotene 0.045% Lotion

Tazarotene 0.045% Lotion
Adapalene 0.3% Gel
Control

Tazarotene 0.045% Lotion
Adapalene 0.3% Gel
Control

0.0

0.5

1.0

1.5

2.0

2.5

3.0

1 2 3 4 5 6

M
e
a
n
 S

co
re

, 
D

e
rm

a
l 
E

ff
e
ct

s

A. Dermal Effects B. Other Effects

M
e
a
n
 S

co
re

, 
O

th
e
r 

E
ff

e
ct

s

0.0

0.5

1.0

1.5

2.0

2.5

3.0

1 2 3 4 5 6

Visit Visit

1=Minimal 
erythema; 
barely
perceptible

2=Definite 
erythema,
readily visible; 
minimal edema/
papular response

3=Erythema 
and papules

3=Glazing 
with peeling 
and cracking

2=Marked 
glazing

1=Slight 
glazed 
appearance

*P<0.05; **P<0.01; ***P<0.001 vs control.
Patches were applied at visits 1–5 after any skin assessments were made.
Visits 1–6 correspond to study days 1, 3, 5, 8, 10, and 12, respectively.

FIGURE 3. Study 2: Irritation Potential of Trifarotene 0.005% Cream vs 
Tazarotene 0.045% Lotion

Tazarotene 0.045% Lotion
Trifarotene 0.005% Cream
Control

Tazarotene 0.045% Lotion
Trifarotene 0.005% Cream
Control

0.0

0.5

1.0

1.5

2.0

2.5

3.0

1 2 3 4 5 6

M
e
a
n
 S

co
re

, 
D

e
rm

a
l 
E

ff
e
ct

s

A. Dermal Effects B. Other Effects
M

e
a
n
 S

co
re

, 
O

th
e
r 

E
ff

e
ct

s

0.0

Visit Visit

0.5

1.0

1.5

2.0

2.5

3.0

1 2 3 4 5 6

1=Slight 
glazed 
appearance

2=Marked 
glazing

3=Glazing 
with peeling 
and cracking

1=Minimal 
erythema; 
barely
perceptible

2=Definite 
erythema,
readily visible; 
minimal edema/
papular response

3=Erythema 
and papules

*P<0.05; **P<0.01; ***P≤0.001 vs control. #P<0.05; ##P<0.01; ###P≤0.001 trifarotene 0.005% cream vs tazarotene 0.045% lotion.
Patches were applied at visits 1–5 after any skin assessments were made.
Visits 1–6 correspond to study days 1, 3, 5, 8, 10, and 12, respectively.

Study 2: Trifarotene 0.005% Cream vs Tazarotene 0.045% Lotion
 � 20 adults (22–74 years; 90% female; 90% White, 10% African American) were enrolled and 
completed this study

 � Dermal Effects mean scores with trifarotene cream were significantly greater than with 
tazarotene lotion at the first assessment (2 days after first patch application; P<0.05) and 
increased over the remaining visits (highest mean scores: 2.20 vs 0.70, respectively; P<0.001, all; 
Figure 3)

 � Other Effects mean scores were significantly greater with trifarotene cream than with 
tazarotene lotion, beginning at the second assessment (4 days after first patch application) and 
continuing through remaining visits (highest mean scores: 0.70 vs 0.20, respectively; P<0.01, all)

 � No irritation was observed at the control patch site at any study visit

 � Images of representative participants are shown in Figure 4

FIGURE 4. Study 2: Participant Photographs at Visit 6 (Day 12; Final Assessment)

Control TazaroteneTrifarotene

ControlTazarotene Trifarotene

42-year-old male

Effects Score

Trifarotene
Tazarotene
Control

Dermal

3
0
0

Other

1
0
0

30-year-old female

Effects Score

Trifarotene
Tazarotene
Control

Dermal Other

2
1
0

1
0
0

Individual results may vary.

REFERENCES
1. Leyden J, et al. J Drugs Dermatol. 2004;3(6):341–651.
2. Baldwin H, et al. Am J Clin Dermatol. 2021;22:315–327.
3. Tanghetti EA, et al. J Dermatolog Treat. 2019;1–8.
4. Culp L, et al. J Cutan Med Surg. 2015;19(6):530–538.

AUTHOR DISCLOSURES
Zoe Draelos received funding from Ortho Dermatologics to conduct 
the research presented in this poster. Patricia Farris serves as an 
advisor, speaker or consultant to Beauty, La Roche Posay, NeoStrata, 
Neutrogena, Nutraceutical Wellness, and USK. Hilary Baldwin has 
served as advisor, investigator, and on speakers’ bureaus for Almirall, 
Cassiopea, Foamix, Galderma, Ortho Dermatologics, Sol Gel, and 
Sun Pharma. Emil Tanghetti has served as speaker for Novartis, 
Ortho Dermatologics, Sun Pharma, Lilly, Galderma, AbbVie, and 
Dermira; served as a consultant/clinical studies for Hologic, Ortho 
Dermatologics, and Galderma; and is a stockholder for Accure.

CONCLUSIONS
 � In a modified cumulative irritation 
study, tazarotene 0.045% lotion 
was significantly less irritating than 
trifarotene 0.005% cream

 � Tazarotene 0.045% lotion was 
numerically less irritating than 
adapalene 0.3% gel, one of the 
best-tolerated topical retinoids2,4

 � Tazarotene 0.045% lotion allows 
for simultaneous, uniform, and 
rapid delivery of hydrating 
ingredients along with less than 
half the concentration of 
tazarotene versus other 
commercially available 0.1% 
formulations3

• The lower retinoid concentration 
combined with moisturizing/
hydrating ingredients (sorbitol, 
light mineral oil, diethyl sebacate, 
water3) in a proprietary polymeric 
mesh vehicle may help minimize 
instances of retinoid-induced 
irritationFIGURE 1. Study Design

Visit 1
(Day 1)

Visit 2
(Day 3)

Visit 3
(Day 5)

Visit 4
(Day 8)

Visit 5
(Day 10)

Visit 6
(Day 12)

Patches placed:

Irritation assessed:

Tazarotene 0.045% Lotion
Adapalene 0.3% Gel
Control (no drug)

Study 1:

Tazarotene 0.045% Lotion
Study 2:

Trifarotene 0.005% Cream
Control (no drug)

The order of patches on participants’ backs was randomized.