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 Fall Clinical Dermatology Conference • October 21-24, 2021 • Las Vegas, NV

REFERENCES
1. Tanghetti EA, et al. J Dermatol Treat. 2019:1–8.
2. Tanghetti EA, et al. J Drugs Dermatol. 

2019;18(6):542–548. 

3. Chandraratna RAS. J Amer Acad
Dermatol. 1997;18(6): 542–548.

4. Finzl E, et al. Am J Pathol. 1992;140(6):1463–1471.

AUTHOR DISCLOSURES
Zoe Draelos received funding from Ortho Dermatologics to conduct the research presented here. 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. Linda Stein Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, 
Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis and Lilly. Hilary Baldwin has served as advisor, 
investigator, and on speakers’ bureaus for Almirall, Cassiopea, Foamix, Galderma, Ortho Dermatologics, Sol Gel, and 
Sun Pharma. Leon Kircik has acted as an investigator, advisor, speaker, and consultant for Ortho Dermatologics. Eric 
Guenin is an employee of Ortho Dermatologics and may hold stock and/or stock options in its parent company.

INTRODUCTION AND 
FORMULATION

 � Tazarotene 0.045% lotion was developed 
using polymeric emulsion technology to 
provide uniform and rapid distribution of the 
active ingredient and hydrating excipients at 
the skin surface and to efficiently deliver 
tazarotene into skin1

 � Tolerability may be improved by the vehicle 
design and the homogenous nature of the 
delivery as well as the lower dose of 
tazarotene used compared with all other 
tazarotene formulations2

  Polymeric Emulsion Technology for 
  Tazarotene 0.045% Lotion

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

25-50 μm

1-2 μm ①

②

③

SKIN DEPOSITION: 
TAZAROTENE 0.045% LOTION VS TAZAROTENE 0.1% CREAM 
DRAELOS ZD AND DRAELOS MM. J DRUGS DERMATOL. 2021; IN PRESS.

Results
 � 10 female White participants aged 19–59 years completed the study
 � At 6 hours post application, most tazarotene remained on the skin 
surface, as indicated by the higher tazarotene concentrations recovered 
from superficial (tape strip 2) versus deeper skin layers (tape strip 20)

 � Concentration of tazarotene was approximately 2-fold higher for 
0.1% cream vs 0.045% lotion at both superficial and deep skin layers, 
but the absolute difference drastically decreased in deeper layers

Tazarotene
0.045% Lotion

Tazarotene
0.1% Cream

2

4

6

8

10

12

14

16

18

20

Ta
pe

 S
tr

ip
 N

um
be

r

Superficial
Dermis

   
 D

ee
pe

r s
ki

n 
la

ye
rs

   
 D

ee
pe

r s
ki

n 
la

ye
rs

Stratum
corneum

• Higher tazarotene concentrations remained at super�cial vs deeper layers
• Difference in concentration between formulations drastically decreased

in deeper layers

Cream minus Lotion
(µg/mL)

0.80

0.42

0.31

0.20

0.19

0.09

0.10

0.12

0.07

0.09

Dot area corresponds to tazarotene concentration. Skin layers shown for illustrative 
purposes only. Exact location of tape strip sampling within the skin is unknown. 
LC-MS, liquid chromatography-mass spectrometry.

Tazarotene 0.045% Lotion for Acne: Formulation, Application Characteristics, and Clinical Efficacy and Safety
Zoe D Draelos, MD1; Emil A Tanghetti, MD2; Linda Stein Gold, MD3; Hilary Baldwin, MD4,5; Leon H Kircik, MD6,7,8; Eric Guenin, PharmD, PhD, MPH9
1Dermatology Consulting Services, PLLC, High Point, NC; 2Center for Dermatology and Laser Surgery, Sacramento, CA; 3Henry Ford Hospital, Detroit, MI; 4The Acne Treatment and Research Center, Brooklyn, NY; 5Robert Wood Johnson University Hospital, New Brunswick, NJ; 6Indiana University School of Medicine, Indianapolis, IN; 
7Physicians Skin Care, PLLC, Louisville, KY; 8Icahn School of Medicine at Mount Sinai, New York, NY; 9Ortho Dermatologics,* Bridgewater, NJ 
*Ortho Dermatologics is a division of Bausch Health US, LLC

SPREADABILITY:  
TAZAROTENE 0.045% LOTION VS TRIFAROTENE 0.005% CREAM

 � Skin coverage with tazarotene 0.045% lotion was compared to 
trifarotene 0.005% cream in a double-blind split-body study of 30 
healthy adults (aged 18-59 years)

 � Each product (0.1 mL) was applied to a 10 cm wide area on one side of 
participants’ backs until it would no longer spread; area of spread was 
then determined

Results
 � The average area of spread for tazarotene 0.045% lotion and 
trifarotene 0.005% cream was 167.0 and 130.3 cm2, respectively 
(difference = 36.7 cm2; P<0.001)

Participant Example 

Tazarotene 
0.045% Lotion

Trifarotene 
0.005% Cream

CONCLUSIONS
 � Tazarotene 0.045% lotion utilizes 
polymeric emulsion technology to 
enhance hydration, moisturization, 
and skin barrier function

 � This easy-to-apply lotion, with 
sensory and aesthetic properties 
preferred by patients, appears to 
have greater skin coverage compared 
with trifarotene cream

 � There is superior tolerability of 
tazarotene 0.045% lotion versus 
tazarotene 0.1% cream, with similar 
clinical efficacy

• Tazarotene is a potent activator of
retinoic acid gamma receptors
(enriched
throughout
skin3,4); thus,
lower levels in
deeper skin with
tazarotene
0.045% lotion vs
0.1% cream are
sufficient for
clinical effect

• Superior
tolerability of
tazarotene
0.045% lotion
vs 0.1% cream
may be due
to lower drug
concentration at
superficial epidermal layers

 � Tazarotene 0.045% lotion is a 
beneficial treatment option for acne 
in patients aged 9 and older, 
delivered in an easy-to-spread 
formulation that can be applied to 
the face, back, and chest

PHASE 2 STUDY: 
TAZAROTENE 0.045% LOTION, 
TAZAROTENE 0.1% CREAM, AND VEHICLE
TANGHETTI EA, ET AL. J DRUGS DERMATOL. 2019;18(6):542–548.

 � A total of 210 participants aged ≥12 years with moderate-to-severe acne 
(Evaluator’s Global Severity Score [EGSS] of 3 or 4) were randomized 
(2:2:1:1) to receive once-daily tazarotene 0.045% lotion, tazarotene 0.1% 
cream, lotion vehicle, or cream vehicle for 12 weeks

Results
 � Tazarotene 0.045% lotion demonstrated significantly greater mean 
percent reductions in inflammatory and noninflammatory lesion counts 
vs vehicle at week 12 

 � Rates of treatment-emergent adverse events (TEAEs), serious adverse 
events, and treatment-related TEAEs were lower with tazarotene 0.045% 
lotion compared with tazarotene 0.1% cream

-20%

0%

-40%

-60%

-80%

-100%

#(

-63.8%

In�ammatory
Lesions

M
e
a
n
 P

e
rc

e
n
t 

C
h
a
n
g

e
F
ro

m
 B

a
se

lin
e
 t

o
 W

e
e
k
 1

2

-60.0%

-51.4%
-56.9%

Nonin�ammatory
Lesions

-54.1%

-35.2%

TAZ 0.045% Lotion (n=69)

ITT Population

TAZ 0.1% Cream (n=72)

Combined Vehicle (n=69)

TEAE Summary, 
Safety Population

TAZ 0.045%
Lotion (n=68)

TAZ 0.1%
Cream (n=71)

Combined
Vehicle (n=67)

Any TEAE 14.7% 26.8% 13.4%

Any SAE 0% 0% 0%

Any TEAE related to
treatment 2.9% 5.6% 0%

Tazarotene 0.045% Lotion:
• Signi�cantly superior to vehicle
• Comparable ef�cacy to cream
• Fewer adverse events than cream

**P<0.01, ***P<0.001 vs combined vehicle.  
Statistical comparison between TAZ 0.1% cream and combined vehicle was not conducted. 
At week 12, a greater percentage of tazarotene 0.045%-treated participants achieved 
treatment success versus combined vehicle (18.8% vs 10.1%), though this difference did not 
reach statistical significance.  
ITT, intent to treat; SAE, serious adverse event; TAZ, tazarotene; TEAE, treatment-emergent 
adverse event.

Drug
concentration

Potential for
irritation

Sufficient for
efficacy

Superficial
dermis

Stratum
corneum

PATIENT PREFERENCE
TANGHETTI EA, ET AL. J DERMATOL TREAT. 2019;1–8.

 � Healthy female participants aged 
35–65 years (N=15) answered a  
questionnaire on the properties of the 
vehicle lotion for tazarotene 0.045% 

Results
 � Most participants (93–100%) responded 
favorably (strongly agree or agree) to all 
questions about the various attributes of 
the vehicle lotion after application

My skin feels…

The product… 

CORNEOMETRY AND  
TRANSEPIDERMAL WATER LOSS (TEWL)
TANGHETTI EA, ET AL. J DERMATOL TREAT. 2019;1–8.

 � Skin hydration and epidermal barrier maintenance with the vehicle lotion 
were assessed through corneometry and TEWL (N=30)

Results
 � The vehicle lotion provided rapid and sustained increases in skin 
moisturization (left) and improved barrier function (right) 

Skin Moisturization Assessment Skin Barrier Assessment 
Using Corneometry (N=30) Using TEWL (N=30)

0

10

20

30

40

50

60

70

0 0.25 1 8 24
0

2

4

6

8

10

12

14

16

0 0.25 1 8 24

M
e
a
n
 S

co
re

s 
±

 S
D

 

M
e
a
n
 S

co
re

s 
±

 S
D

 

Vehicle Lotion
Untreated Control

Hours Hours

Vehicle Lotion
Untreated Control

***P<0.001 vs untreated control. SD, standard deviation.

1 2 3 4

Post-application: 
tape strips applied 
and held for 10 sec 
using a controlled 
pressure plunger

Tape strips removed. 
First strip discarded;  
20 additional strips 
taken at same 
sampling location 
(frozen until 
analysis)

Even-numbered 
tape strips 
processed and 
analyzed for 
tazarotene using 
LC-MS

~1 g of each  
product (blue and 
green) applied to 
square areas on  
each forearm