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 The Fall Clinical Dermatology Conference for PAs and NPs • June 3-5, 2022 • Scottsdale, AZ
SYNOPSIS
� Truncal acne (occurring on the chest and back) is
common among patients with facial acne,1-3
though its pathophysiology may be somewhat
different4,5
� As there are no specific guidelines for the
treatment of truncal acne, facial acne treatment
guidelines are often the basis for its management3
� Successful treatment of truncal acne is
complicated by the involvement of a large body
surface area that is typically covered in clothing3
� Topical vehicles that provide ease of spreadability,
rapid cutaneous penetration/effective drug
delivery, and lack of residue are highly desirable
for truncal acne treatment1
� A lower-dose tazarotene 0.045% lotion
formulation (Arazlo®; Ortho Dermatologics) was
developed utilizing polymeric emulsion
technology (Figure 1)6
• This highly spreadable lotion formulation was
developed to allow for more efficient delivery of
tazarotene into dermal layers
• In phase 1 studies, this lotion demonstrated low
irritation/contact dermatitis potential and no
allergic sensitization7
OBJECTIVES
� Study 1: to summarize the efficacy, safety, and
tolerability of tazarotene 0.045% lotion in the
treatment of truncal acne
� Study 2: to evaluate the spreadability of
tazarotene 0.045% lotion and trifarotene 0.005%
cream on the trunk
FIGURE 1. Polymeric Emulsion Technology for
Tazarotene 0.045% Lotion
1-2 μm
①
②
③
① Polymeric matrix holds water and water-soluble
hydrating agents within a 3-D mesh
② Droplets of tazarotene and oil-soluble
moisturizing agents held apart by the 3-D mesh
③ 3-D mesh allows for uniform distribution of
tazarotene and moisturizing agents
STUDY 2: SPREADABILITY
Tazarotene 0.045% Lotion vs Trifarotene 0.005% Cream8
Study 2 Design
• Double-blind split-body study of 30 healthy adults (18–59 years)
• Each product (0.1 mL) was applied to a 10 cm wide area on one side of participants’ backs and
moved down the back until it would no longer spread; area of spread was then determined
160
0
40
80
120
167.0
Tazarotene
0.045%
Lotion
M
e
a
n
A
re
a
o
f
P
ro
d
u
ct
S
p
re
a
d
(
cm
2
)
130.3
200
Trifarotene
0.005%
Cream
Tazarotene
0.045% Lotion
Trifarotene
0.005% Cream
Mean Spreadability of Tazarotene
Lotion and Trifarotene Cream (N=30) Participant example
***P<0.001 vs trifarotene 0.005% cream.
Mean
difference:
36.7 cm2
• On average,
skin coverage
with tazarotene
0.045% lotion
was ~30%
greater than
with trifarotene
0.005% cream
Tazarotene 0.045% Lotion for Truncal Acne: Efficacy, Safety, and Spreadability
Leon H Kircik, MD1-3; Zoe D Draelos, MD4; Eric Guenin, PharmD, PhD, MPH5
1Icahn School of Medicine at Mount Sinai, New York, NY; 2Indiana University Medical Center, Indianapolis, IN; 3Physicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY; 4Dermatology Consulting Services, PLLC, High Point, NC; 5Ortho Dermatologics, Bridgewater, NJ*
*Ortho Dermatologics is a division of Bausch Health US, LLC
FIG
CONCLUSIONS
� Tazarotene 0.045% lotion utilizes polymeric emulsion technology to enhance hydration,
moisturization, and skin barrier function
� Tazarotene 0.045% lotion led to significant reductions in truncal acne severity and
lesion counts; ~90% of participants achieved clear or almost clear skin with 12 weeks of
once-daily use and most participants had no tolerability issues
� This easy-to-apply tazarotene lotion has sensory and aesthetic properties preferred by
patients6 and resulted in ~30% greater skin coverage compared with trifarotene cream
• Less product needed to cover the same skin area equals more applications per unit volume
REFERENCES
1. Del Rosso JQ. Cutis. 2006;77:285–289.
2. Dréno B, et al. JEADV. 2015;29(6):1096–1106.
3. Poli F, et al. JEADV. 2020;34(10):2241–2246.
4. Short RW, et al. Pediatr Dermatol. 25(1):126–128.
5. Kim BR, et al. Dermatol. 231:87–93.
6. Tanghetti EA, et al. J Dermatol Treat. 2019;Sept 26:1–8.
7. Kircik LH, et al. J Dermatol Treat. 2121;Aug 30:1–9.
8. Draelos ZD, et al. J Drugs Dermatol. 2021;21(3):250–257.
AUTHOR DISCLOSURES
Leon H Kircik has acted as an investigator, advisor, speaker, and consultant for Ortho Dermatologics. Zoe D Draelos received funding from Ortho Dermatologics
to conduct the research presented here. Eric Guenin is an employee of Ortho Dermatologics and may hold stock and/or stock options in its parent company.
STUDY 1: EFFICACY, SAFETY, AND TOLERABILITY IN TRUNCAL ACNE
Tazarotene 0.045% Lotion
• Most
participants
had no
tolerability
issues
• There were
no signi�cant
changes
from baseline
to week 12
in any
tolerability
assessment
Total Lesion Reductions
-100%
-60%
-40%
-20%
0%
Baseline Week 4 Week 8 Week 12
LS
M
e
a
n
P
e
rc
e
n
t
C
h
a
n
g
e
F
ro
m
B
a
se
lin
e
-80%
-44.9%
***
Tazarotene 0.045% Lotion (n=19)
-67.7%
***
-82.3%
***
LS mean percent changes from baseline:
IL -49.4%*** -63.8%*** -83.3%***
NIL -7.6%* -59.3%** -64.3%**
Cutaneous Tolerability and Safety
0%
40%
60%
80%
100%
P
e
rc
e
n
ta
g
e
o
f
P
a
rt
ic
ip
a
n
ts
20%
BL, baseline. There were no adverse events related to tazarotene treatment in this study.
Clear/Almost Clear Skin
0%
40%
60%
80%
100%
Baseline Week 4 Week 8 Week 12
P
e
rc
e
n
ta
g
e
o
f
P
a
rt
ic
ip
a
n
ts
20%
***
21%
Tazarotene 0.045% Lotion (n=19)
***
47%
***
89%
Truncal Ef�cacy
*P<0.05; **P<0.01; ***P<0.001 vs baseline.
IL, in�ammatory lesions; LS, least squares; NIL, nonin�ammatory lesions.
Severity: None Trace Mild
Patient Preference Questionnaire
Ointment
Cream
Lotion
Spray
Gel
Not all participants responded to all items on the questionnaire; percentages for each item are based upon the number of participants who responded to that item.
Percentage of Participants
6 11 17 67
6 11 67 116
21 32 5 1132
18 29 6 641
53 18 6 1212
Product Rank: 5=Liked Least 4 3 2 1=Liked Best
Ranked Preference for Past Skin Medicines
Percentage of Participants
Ratings of Tazarotene 0.045% Lotion
20 40 60 80 100
Percentage of participants rating the lotion as
“good” or “excellent” compared to other medicines
Easy to Use
Continue Daily
Activities
Large Surface
Area Application
Lotion
Disappears
Soft Skin
0
88%
83%
80%
75%
64%
Study 1 Design
• Participants aged ≥12 years
• Moderate truncal acne
(Investigator’s Global
Assessment score = 3)
• Once-daily treatment with
tazarotene 0.045% lotion
for 12 weeks
• Age (mean): 24.1 years
• Sex: 52.6% female
• Race: 52.6% White,
36.8% Black, 10.5% Biracial
Demographics
At Week 12:
• ~90% achieved
clear or almost
clear skin
• >80% reductions
from baseline in
total lesion counts
BL Wk12
11%
90%
100%
Peeling
BL Wk12
11%
16%
74%
5%
21%
74%
Erythema
BL Wk12
11%
90%
100%
Dryness
BL Wk12
95%
5%
95%
Oiliness
5%
BL Wk12
16%
84%
11%
5%
84%
Pruritus
BL Wk12
5%
95%
11%
5%
84%
Burning
• Overall, participants
preferred lotions
over other types
of topical treatments
• Most participants
(64–88%) rated
attributes of
tazarotene 0.045%
lotion as “good”
or “excellent” in
comparison to
other medications