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 2020 • October 29 - November 1, 2020 • Virtual

SYNOPSIS
 � In the treatment of psoriasis, combining tazarotene (TAZ) with a potent topical steroid, 
such as the superpotent corticosteroid halobetasol propionate (HP), is recommended for 
patients with mild-to-moderate disease1 

 � The TAZ + HP combination may provide synergistic efficacy, increase the duration of 
treatment effect and time of remission, and reduce side effects of both HP and TAZ1-3

 � Topical psoriasis therapy has also been recommended for patients with lower levels of 
body surface area (BSA) involvement4; though these patients may be deemed more 
“mild,” they may nonetheless have disease characteristics that severely impact their 
quality of life (QoL) 

 � A once-daily, fixed combination HP 0.01%/TAZ 0.045% lotion (Duobrii,® Ortho Dermatologics) 
was developed to address these unmet needs in the topical treatment of psoriasis

OBJECTIVE
 � To evaluate the efficacy, impact on QoL, and safety of HP 0.01%/TAZ 0.045% lotion versus 
vehicle in patients with lower levels of BSA involvement (3–5%) at baseline

METHODS

FIGURE 1.  Phase 3, Randomized, Double-Blind, Vehicle Controlled Studies of 
Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion5,6

Randomized, Double-Blind,
Vehicle-Controlled Treatment

Study 1
(NCT02462070)

Posttreatment
Follow-Up

(No Treatment)

Baseline

2:1

Week 12

HP/TAZ Lotion (n=135)

Vehicle Lotion (n=68)

Week 8

Study 2
(NCT02462122)

2:1 HP/TAZ Lotion (n=141)

Vehicle Lotion (n=74)

Baseline

2:1

Week 12

Key Eligibility Criteria:
• ≥18 years old
• IGA of 3 (moderate) or 
   4 (severe)
• Affected BSA 3% to 12%

Assessments:
• Treatment successa

• Affected BSA
• DLQI
• Adverse events and local 
   skin reactions

Week 8

2:1

Pooled, Post Hoc Analysis:
• Conducted in 232 participants 
   with 3–5% BSA (HP/TAZ lotion, 
   n=149; vehicle lotion, n=83)

aDefined as percentage of participants achieving ≥2-grade reduction from baseline in IGA and a score of ‘clear’ (0) or ‘almost clear’ (1). 
In these studies, CeraVe® hydrating cleanser and CeraVe® moisturizing lotion (L’Oreal, NY) were provided as needed for optimal moisturization/
cleaning of the skin. 
BSA, body surface area; DLQI, Dermatology Life Quality Index; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator’s 
Global Assessment; ITT, intent to treat.

RESULTS

Demographics and Baseline Characteristics
 � A total of 418 participants were included in the overall study population (baseline BSA of 
3–12%; mean: 5.9%); of these participants, 232 (55.5%) had baseline BSA of 3–5% (mean: 
3.8%)

 � Participant demographics (age, sex, race) were similar between groups, though a higher 
proportion of participants with 3–5% BSA had a baseline Investigator’s Global 
Assessment (IGA) score of 3 (moderate; 91.8%) versus the overall population (85.2%) 

FIGURE 4.  Clinically Meaningful Improvement in Quality of Lifea in 3–5% BSA 
Subgroup and Overall Populationb (ITT Population, Pooled)

20%

40%

60%

80%

P
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rc

e
n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

 A
ch

ie
vi

n
g

≥
4
-g

ra
d

e
 R

e
d

u
ct

io
n
 i
n
 D

LQ
I 

0%
4 8 12

Study Visit (Weeks)

Treatment Posttreatment
HP/TAZ Lotion: BSA 3-5% (n=149)
HP/TAZ Lotion: Overall (n=200)
Vehicle Lotion: BSA 3-5% (n=83)
Vehicle Lotion: Overall (n=107)

0

**
****

HP/TAZ Lotion:
• Significantly superior to vehicle at week 8 in improving quality of life

Maintenance of effect:
• Statistical superiority maintained 4 weeks posttreatment

*P<0.05 vs vehicle; **P<0.01 vs vehicle. 
aDefined as ≥4-point reduction (improvement) in DLQI Score7. 
bOverall population had baseline BSA ranging from 3 to 12%. 
Total DLQI score ranges from 0–30, with higher scores indicating worse quality of life. N values shown for baseline. 
BSA, body surface area; DLQI, Dermatology Life Quality Index; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; ITT, intent to treat.

FIGURE 5.  Improvement of Psoriasis With Once-Daily HP/TAZ Lotion

Baseline Week 4

Week 8 Week 12

Target Lesion 

This figure shows representative images from a single participant (target lesion on upper back). 
Participant BSA: baseline, 3%; weeks 4, 8, and 12, 1%. 
Participant IGA: baseline, 3 (moderate); weeks 4, 8, and 12, 1 (almost clear). 
Participant DLQI: baseline, 5; week 4, 0; week 8, 1; week 12, 0. 
BSA, body surface area; DLQI, Dermatology Life Quality Index; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator’s 
Global Assessment.

Adverse Events  
 � Incidence of treatment-emergent adverse events (TEAEs) with HP/TAZ was similar 
between the BSA 3–5% subgroup and the overall population; the most common TEAEs 
were also similar between groups (Table 1) 

 � In a separate analysis by baseline IGA, HP/TAZ-treated participants with moderate 
psoriasis (IGA 3) experienced fewer irritation-related AEs than those with severe psoriasis 
(IGA 4; data not shown)

Halobetasol 0.01%/Tazarotene 0.045% (HP/TAZ) Lotion for the Treatment of Plaque Psoriasis in Patients  
With 3-5% Body Surface Area

Efficacy and Quality of Life
FIGURE 2.  Treatment Successa in 3–5% BSA Subgroup and Overall Populationb 

(ITT Population, Pooled)

P
e
rc

e
n
ta

g
e
 o

f 
P
a
rt

ic
ip

a
n
ts

0%

10%

20%

30%

40%

50%

60%

0 2 4 6 8 12
Study Visit (Weeks)

Treatment Posttreatment

******

HP/TAZ Lotion: BSA 3-5% (n=149)
HP/TAZ Lotion: Overall (n=276)
Vehicle Lotion: BSA 3-5% (n=83)
Vehicle Lotion: Overall (n=142)

HP/TAZ Lotion:
• Significantly superior to vehicle at all study visits
• Over 40% of participants achieved treatment success at week 8

Maintenance of effect:
• Statistical superiority maintained 4 weeks posttreatment
• Of the participants that achieved treatment success at week 8, most maintained success at week 12 
   • 3–5% BSA: 63.3% maintained
   • Overall: 62.4% maintained

***

***
***

******
******

*P<0.05 vs vehicle; **P<0.01 vs vehicle; ***P<0.001 vs vehicle. 
aDefined as percentage of participants achieving ≥2-grade reduction from baseline IGA and a score of ‘clear’ (0) or ‘almost clear’ (1).  
bOverall population had baseline BSA ranging from 3 to 12%. 
BSA, body surface area; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator’s Global Assessment; ITT, intent to treat.

FIGURE 3.  BSA Reduction in 3–5% BSA Subgroup and Overall Populationa 
(ITT Population, Pooled)

0%

-50%

-40%

-30%

-20%

-10%

10%

M
e
a
n
 P

e
rc

e
n
t 

C
h
a
n
g

e
 F

ro
m

 B
a
se

lin
e

-60%
2 4 6 8 12

Study Visit (Weeks)

Treatment Posttreatment

HP/TAZ Lotion: BSA 3-5% (n=149)
HP/TAZ Lotion: Overall (n=276)
Vehicle Lotion: BSA 3-5% (n=83)
Vehicle Lotion: Overall (n=142)

0

**** ******
******

******
******

HP/TAZ Lotion:
• Significantly superior to vehicle at all study visits
• Over 35% reduction in BSA from baseline to week 8

Maintenance of effect:
• Statistical superiority maintained 4 weeks posttreatment

**P<0.01 vs vehicle; ***P<0.001 vs vehicle. 
aOverall population had baseline BSA ranging from 3 to 12%. 
BSA, body surface area; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; ITT, intent to treat.

TABLE 1. Treatment-Emergent Adverse Events

BSA 3–5% Subgroup Overall Population 
HP/TAZ 
Lotion 
(n=148)

Vehicle 
Lotion  
(n=82)

HP/TAZ 
Lotion 
(n=270)

Vehicle 
Lotion 
(n=140)

Any TEAE, n (%) 55 (37.2) 16 (19.5) 97 (35.9) 30 (21.4)
Most common TEAEsa, n (%)
    Contact dermatitis 11 (7.4) 0 20 (7.4) 0
    Pruritis 4 (2.7) 2 (2.4) 8 (3.0) 4 (2.9)
    Folliculitis 4 (2.7) 0 5 (1.9) 0
    Burning sensationb 4 (2.7) 1 (1.2) 4 (1.5) 3 (2.1)
    Application site pain 3 (2.0) 0 7 (2.6) 1 (0.7)
    Nasopharyngitisc 2 (1.4) 2 (2.4) 5 (1.9) 4 (2.9)

aAt least 2.5% incidence in any treatment group. 
bSystem Organ Class: nervous system disorder. 
cNo instances were considered by the investigator to be treatment related. 
BSA, body surface area; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; TEAE, treatment-emergent adverse event.

 � Skin atrophy was reported as an AE in 5 (1.9%) participants who received HP/TAZ lotion; 
of those, 2 (1.4%) had baseline BSA 3–5% 

• No participants who received vehicle reported skin atrophy as an AE

Local Skin Reactions 
 � Itching, dryness, and burning/stinging showed improvements over 8 weeks of HP/TAZ 
treatment in the BSA 3–5% subgroup and the overall population (data not shown)

 � In HP/TAZ-treated participants; the BSA 3–5% subgroup and overall population had low 
peak incidence of skin atrophy (4.4% and 2.9%, respectively), striae (0.7% and 1.3%), 
telangiectasias (0.7% and 0.8%), and folliculitis (2.2% and 2.9%)

• Incidence peaked at week 8 for all assessments except telangiectasias, which peaked at 
week 6 in the overall population 

• Among participants treated with vehicle lotion, incidence of these local skin reactions 
was 0.5%-1.5% at all study visits

CONCLUSIONS
 � In two pooled phase 3 studies, HP/TAZ lotion demonstrated rapid 
efficacy versus vehicle and clinically meaningful improvement in QoL 
among participants with lower (3–5%) affected BSA at baseline, with 
improvements maintained 4 weeks posttreatment

 � HP/TAZ lotion was well tolerated, with low rates of skin atrophy and 
other local skin reactions 

 � HP/TAZ lotion may be an effective and well tolerated option for the 
treatment of “milder” psoriasis in patients with lower BSA involvement

REFERENCES
1. Elmets CA, et al. J Am Acad Dermatol. Online ahead of print,  

2020 Jul 30. doi:10.1016/j.jaad.2020.07.087.
2. Tanghetti E, et al. J Dermatolog Treat. 2019:1-8.
3. Kircik LH, et al. J Drugs Dermatol. 2019;18(3):279-284.

4. Strober B, et al. J Am Acad Dermatol. 2020;82(1):117-122. 
5. Stein Gold L, et al. J Am Acad Dermatol. 2018;79(2):287-293. 
6. Sugarman JL, et al. J Drugs Dermatol. 2018;17(8):855-861.
7. Basra MK, et al. Dermatology. 2015;230(1):27-33.

AUTHOR DISCLOSURES
CL is a consultant for AbbVie, Amgen, Boehringer Ingelheim, Dermira, Eli Lilly, Janssen, LEO Pharma, Pfizer, Sandoz, UCB, and Vitae; an investigator for 
Actavis, AbbVie, Allergan, Amgen, Boehringer Ingelheim, Celgene, Coherus, Cellceutix, Corrona, Dermira, Eli Lilly, Galderma, Glenmark, Janssen, LEO 
Pharma, Merck, Novartis, Novella, Pfizer, Sandoz, Sienna, Stiefel, UCB, and Wyeth; and a speaker for AbbVie, Celgene, Novartis, Sun Pharmaceutical, and Eli 
Lilly. LSG has served as investigator/consultant or speaker for Ortho Dermatologics, LEO, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun, UCB, Arcutis and 
Lilly. EL has nothing to disclose. AN has received grants/research funding from Amgen, Celgene, Chugai Pharma, Janssen (Johnson & Johnson) , Maruho, 
Novartis, Pfizer, Regeneron, and Xoma; fellowship funding from AbbVie and Janssen (Johnson & Johnson); and has served on advisory boards for Janssen 
(Johnson & Johnson), Abbvie, and Amgen. AJ is an employee of Ortho Dermatologics and may hold stock and/or stock options in its parent company.

Craig Leonardi, MD1; Linda Stein Gold, MD2; Edward Lain, MD, MBA3; Andrea Neimann, MD4; Abby Jacobson, MS, PA-C5
1Department of Dermatology, St. Louis Medical School, St. Louis, MO; 2Henry Ford Hospital, Detroit, MI; 3Austin Institute for Clinical Research, Austin, TX; 4Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York, NY; 5Ortho Dermatologics*, Bridgewater, NJ
*Ortho Dermatologics is a division of Bausch Health US, LLC.