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 dermatologic issue in adolescence, though prevalence of acne in the adult 
population is increasing1

 ◾ Adult females are more likely to report acne than males across all age groups, with prevalence 
ranging from 50.9% (20-29 y) to 15.3% (≥50 y) in females and 42.5% (20-29 y) to 7.3% (≥50 y) in 
males2

 ◾ Adolescent and adult females are also more likely have worse acne-related quality of life3

 ◾ A novel tazarotene 0.045% lotion formulation was developed for the treatment of acne, utilizing 
polymeric emulsion technology, resulting in a more uniform distribution of the active ingredient 
and hydrating excipients at the surface of the skin

 ◾ In a 12-week, randomized, double-blind, vehicle-controlled, parallel group, phase 2 study 
(NCT02938494), tazarotene 0.045% lotion was superior to vehicle on inflammatory/
noninflammatory lesion count reductions in patients with moderate-to-severe acne4

 ◾ In addition, tazarotene 0.045% lotion was as effective as the higher concentration tazarotene 0.1% 
cream (already approved for acne), but with fewer adverse events (AEs)4

OBJECTIVE

 ◾ To evaluate the efficacy and safety of tazarotene 0.045% lotion in females and males

METHODS

 ◾ In this phase 2 study, patients aged 12 years and older were randomized (2:2:1:1) to receive 
tazarotene 0.045% lotion, tazarotene 0.1% cream (Tazorac), lotion vehicle, or cream vehicle

• Participants must have had a score of 3 (moderate) or 4 (severe) on the Evaluator Global Severity 
Score (EGSS) at the screening and baseline visit

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

 ◾ A post hoc analysis was conducted in female and male patients, based on the following co-primary 
efficacy endpoints of the clinical trial:

• Mean absolute change in inflammatory and noninflammatory lesion counts from baseline to 
week 12

• Treatment success, defined as percentage of patients achieving ≥2-grade reduction from 
baseline to week 12 in EGSS and a score of clear (0) or almost clear (1)

 ◾ Safety and adverse events (AEs) were also assessed

RESULTS

 ◾ The intent-to-treat population included 210 participants (males, n=94; females, n=116)

 ◾ At week 12, tazarotene 0.045% lotion-treated females and males had significantly greater  
absolute least-squares mean reductions from baseline versus vehicle in noninflammatory lesion 
counts; only females had significant mean reductions versus vehicle in inflammatory lesion  
counts (Figure 1)

Efficacy and Safety of a Novel Tazarotene 0.045% Lotion in Females and Males With Moderate-to-Severe Acne 

TABLE 1. Treatment-Emergent Adverse Events (Safety Population, Pooled)

Males Females

Participants,  
n (%)

TAZ  
0.045% 
Lotion 
(n=31)

Tazorac  
0.1% 

Cream 
(n=30)

Combined  
Vehicle  
(n=30)

TAZ  
0.045% 
Lotion 
(n=37)

Tazorac 
0.1% 

Cream 
(n=41)

Combined  
Vehicle  
(n=37)

Reporting any TEAE 6 (19.4) 9 (30.0) 4 (13.3) 4 (10.8) 10 (24.4) 5 (13.5)

Reporting any SAE 0 0 0 0 0 0

Discontinued due to TEAE 0 1 (3.3) 0 0 0 0

Severity of TEAEs reported

 Mild 5 (16.1) 6 (20.0) 4 (13.3) 1 (2.7) 6 (14.6) 5 (13.5)

 Moderate 0 3 (10.0) 0 2 (5.4) 4 (9.8) 0

 Severe 1 (3.2) 0 0 1 (2.7) 0 0

Relationship to study drug

 Related 1 (3.2) 0 0 1 (2.7) 4 (9.8) 0

 Unrelated 5 (16.1) 9 (30.0) 4 (13.3) 3 (8.1) 6 (14.6) 5 (13.5)

SAE, serious adverse event; TAZ, tazarotene; TEAE, treatment-emergent adverse event.

FIGURE 1. Mean Change From Baseline to Week 12 in Inflammatory and 
Noninflammatory Lesion Counts in Males and Females (ITT Population, Pooled)

-16.5

-18.8

-13.8
-14.8

-30

-25

-20

-15

-10

-5

0
Males Females

LS
 M

e
a
n
 C

h
a
n
g

e
 F

ro
m

 B
a
se

li
n
e

In�ammatory

TAZ 0.045% Lotion        Combined Vehicle

-21.6
-20.8

-12.0

-14.8

-30

-25

-20

-15

-10

-5

0
Males Females

LS
 M

e
a
n
 C

h
a
n
g

e
 F

ro
m

 B
a
se

li
n
e

Nonin�ammatory

n=32 n=31 n=32 n=31n=37 n=38 n=37 n=38

*P<0.05 vs vehicle; **P<0.01 vs vehicle. 
ITT, intent-to-treat; LS, least squares; TAZ, tazarotene.

 

 ◾ Percent change from baseline in lesion counts by week are shown in Figure 2

 ◾ A larger percentage of tazarotene 0.045% lotion-treated females and males achieved treatment 
success versus vehicle (Figure 3), although this difference was not significant

 ◾ There were no significant differences between the sexes on inflammatory/noninflammatory lesion 
counts or treatment success at week 12, regardless of treatment with tazarotene 0.045% lotion or 
tazarotene 0.1% cream

 ◾ Treatment-emergent AE (TEAE) rates were higher in males than females for both tazarotene 
0.045% lotion and tazarotene 0.1% cream; there were no differences with vehicle (Table1)

FIGURE 3. Percentage of Males and Females With Treatment Success at Week 12a 
(ITT Population, Pooled)

12.5%

24.3%

9.7%
10.5%

0

10%

20%

30%

40%

Males Females

P
e
rc

e
n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

n=32 n=31 n=37 n=38

TAZ 0.045% Lotion        Combined Vehicle

aPercentage of participants achieving ≥2-grade reduction from baseline to week 12 in EGSS and a score of clear (0) or almost 
clear (1). 
Comparisons between TAZ 0.045% lotion and combined vehicle were not significant. 
EGSS, Evaluator’s Global Severity Score; ITT, intent-to-treat; TAZ, tazarotene.

CONCLUSIONS
 ◾ Tazarotene 0.045% lotion was well tolerated and effective versus vehicle in 
reducing inflammatory and noninflammatory lesion counts in females and 
noninflammatory lesion counts in males 

 ◾ Tazarotene 0.045% treated females had greater lesion count reductions and a 
greater percentage achieved treatment success than tazarotene-treated males, 
although these differences did not reach statistical significance

 ◾ Taken together with the improved tolerability of tazarotene 0.045% lotion vs 
tazarotene 0.1% cream,4 this novel lotion formulation is a viable new treatment 
option that is as effective as cream with fewer AEs

REFERENCES
1. Skroza N, et al. J Clin Aesthet Dermatol. 2018;11(1):21-25. 
2. Collier CN, et al. J Am Acad Dermatol. 2008;58(1):56-9. 
3. Gorelick J, et al. J Dermatol Nurses Assoc. 2015;7(3):154-162. 
4. Tanghetti EA, et al. J Drugs Dermatol. 2019;18(6):542.

AUTHOR DISCLOSURES
Dr. Hilary Baldwin has served as advisor, investigator, and on speakers bureau for Almiral, Foamix, Galderma and Ortho Dermatologics. Dr. Lawrence 

Green has served as speaker, consultant, or investigator for Arcutis, Abbvie, Amgen, Celgene, Dermavant, Jannsen, Lilly, MC2, Novartis, Ortho 

Dermatologics, Sienna, SunPharma, and UCB. Dr. Leon Kircik has acted as an investigator, advisor, speaker, and consultant for Ortho Dermatologics. Dr. 

Eric Guenin is an employee of Ortho Dermatologics and may hold stock and/or stock options in its parent company.

Hilary Baldwin, MD1; Lawrence Green, MD2; Leon Kircik, MD3; Eric Guenin, PharmD, PhD, MPH4
1The Acne Treatment and Research Center, Morristown, NJ; 2Department of Dermatology, George Washington University School of Medicine, Washington, DC; 3Indiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; and Icahn School of Medicine at Mount Sinai, 
New York, NY; 4Ortho Dermatologics*, Bridgewater, NJ
*Ortho Dermatologics is a division of Bausch Health US, LLC.

FIGURE 2. Percent Change From Baseline in Inflammatory (A) and Noninflammatory (B) Lesion Counts in Males and Females (ITT Population, Pooled)

-3.2%
-11.4%

-40.7%

-56.5%

-4.0%

-21.1%

-32.8%

-52.9%

-14.5%

-24.3%

-39.5%
-48.7%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%
# * ) ( ' & % " + , *# ** *)

M
e
a
n
 P

e
rc

e
n
t 

C
h
a
n
g

e
 

F
ro

m
 B

a
se

lin
e

Males

TAZ 0.045% Lotion (n=32)
Tazorac 0.1% Cream (n=31)
Combined Vehicle (n=31)

Baseline Week 2 Week 4 Week 8 Week 12

A. In�ammatory Lesion Count

B. Nonin�ammatory Lesion Count

-18.2%

-30.6%

-52.9%

-70.1%

-13.6%

-33.6%

-52.3%

-65.4%

-19.8% -28.3%

-39.4%

-53.6%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%
# * ) ( ' & % " + , *# ** *)

M
e
a
n
 P

e
rc

e
n
t 

C
h
a
n
g

e
 

F
ro

m
 B

a
se

lin
e

Females
Baseline Week 2 Week 4 Week 8 Week 12

-17.6%
-25.9%

-39.7%

-54.1%

-6.9%
-22.0%

-33.1%

-49.9%

-5.4%
-4.6%

-24.0%
-28.2%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%
# * ) ( ' & % " + , *# ** *)

M
e
a
n
 P

e
rc

e
n
t 

C
h
a
n
g

e
 

F
ro

m
 B

a
se

lin
e

Males
Baseline Week 2 Week 4 Week 8 Week 12

-11.6%

-26.7%

-42.6%

-59.2%

-11.0%

-26.9%

-44.7%
-57.2%

-5.8%

-16.3%

-36.4%
-40.9%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%
# * ) ( ' & % " + , *# ** *)

M
e
a
n
 P

e
rc

e
n
t 

C
h
a
n
g

e
 

F
ro

m
 B

a
se

lin
e

Females
Baseline Week 2 Week 4 Week 8 Week 12

TAZ 0.045% Lotion (n=32)
Tazorac 0.1% Cream (n=31)
Combined Vehicle (n=31)

TAZ 0.045% Lotion (n=37)
Tazorac 0.1% Cream (n=41)
Combined Vehicle (n=38)

TAZ 0.045% Lotion (n=37)
Tazorac 0.1% Cream (n=41)
Combined Vehicle (n=38)

Statistical analyses were not performed between treatment groups. ITT, intent-to-treat; TAZ, tazarotene.