ACKNOWLEDGEMENTS: Medical writing support was provided by Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics | Presented at the Fall Clinical Dermatology Conference • October 17-20, 2019 • Las Vegas, NV

SYNOPSIS 

 ◾ Psoriasis is a chronic, immune‑mediated disease that can have frequent exacerbations and 
remissions1,2

 ◾ Topical corticosteroids are the mainstay of psoriasis treatment3; however, safety concerns limit 
their use4

 ◾ Combination therapy may optimize efficacy while minimizing safety and tolerability concerns

 ◾ Few studies have examined the efficacy and safety of topical therapies for the treatment of 
psoriasis in Hispanic patients 

OBJECTIVE

 ◾ To investigate the efficacy, safety, and tolerability following once‑daily application of a fixed 
combination lotion containing halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ; 
Duobrii™ Ortho Dermatologics, Bridgewater, NJ) in Hispanic patients with 
moderate‑to‑severe plaque psoriasis 

METHODS

 ◾ In two phase 3, multicenter, double‑blind, vehicle‑controlled studies (NCT02462070 and 
NCT02462122), participants were randomized (2:1) to receive HP/TAZ or vehicle once‑daily for 
8 weeks, with a 4‑week posttreatment follow‑up5

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

 ◾ Data from these two studies were pooled and analyzed post hoc in a subset of self‑identified 
Hispanic participants

 ◾ Efficacy assessments included treatment success (≥2‑grade improvement from baseline in the 
Investigator Global Assessment [IGA] score and a score of ‘clear’ or ‘almost clear’ [primary 
endpoint]), impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at 
the target lesion, Body Surface Area (BSA), and reduction from baseline in mean IGAxBSA

 ◾ Safety and treatment‑emergent adverse events (TEAEs) were evaluated throughout the study 

RESULTS

 ◾ A total of 115 Hispanic participants were included in this analysis

 ◾ By Week 8, 39.3% of participants achieved treatment success with HP/TAZ compared with 
9.3% on vehicle (P=0.002); this effect was sustained posttreatment (Figure 1)

 ◾ HP/TAZ lotion was also significantly superior in reducing psoriasis signs; at Week 8, 
significantly more HP/TAZ‑treated participants achieved ≥2‑grade improvement in erythema 
(46.8%), plaque elevation (58.1%), and scaling (63.2%) compared with vehicle (12.7%, 11.2%, 
and 22.2%, respectively; P<0.001 all)

Andrew F Alexis, MD, MPH1; Paul S Yamauchi, MD, PhD2; Tina Lin, PharmD3; Gina Martin, MOT4
1Department of Dermatology, Mount Sinai St Luke’s and Mount Sinai West, New York, NY; 2Dermatology Institute & Skin Care Center, Inc., Santa Monica, CA; 3Ortho Dermatologics, Bridgewater, NJ; 4Bausch Health Americas, Petaluma, CA

FIGURE 2. Mean Percent Change From Baseline in IGAxBSA by Study Visit 
(ITT Population; Pooled Data)

HP/TAZ (n=78)
Vehicle (n=37)

-60%

-30%

-40%

-50%

-20%

-10%

10%

0%

20%

Study Visit (Weeks)

M
e
a
n
 P

e
rc

e
n
t 

C
h
a
n
g

e
 F

ro
m

 B
a
se

lin
e

0 2 4 6 8 12

Treatment Posttreatment

*P=0.016 vs vehicle; **P<0.001 vs vehicle.
BSA, body surface area; HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator Global Assessment; ITT, intent‑to‑treat.

 ◾ The most frequently reported treatment‑related TEAEs were contact dermatitis (3.9%) and 
skin atrophy (3.9%; Table 1)

• Four participants (5.3%) treated with HP/TAZ lotion discontinued due to TEAEs

TABLE 1. Summary of Treatment-Emergent Adverse Events Through Week 8 
(Safety Population; Pooled Data)

n (%)
HP/TAZ Lotion

(n=76)
Vehicle Lotion

(n=36)

 Participants reporting any TEAEs 26 (34.2) 8 (22.2)

 Participants reporting any SAEs 1 (1.3) 0

 Deaths 0 0

 Participants discontinuing due to TEAEs 4 (5.3) 2 (5.6)

Severity of TEAEs

 Mild 11 (14.5) 4 (11.1)

 Moderate 12 (15.8) 3 (8.3)

 Severe 3 (3.9) 1 (2.8)

Relationship to study drug

 Related 14 (18.4) 3 (8.3)

 Unrelated 12 (15.8) 5 (13.9)

Treatment‑Related TEAEs reported in ≥2% of participants

 Contact dermatitis 3 (3.9) 0

 Skin atrophy 3 (3.9) 0

 Burning sensation 2 (2.6) 1 (2.8)

 Pruritis 1 (1.3) 1 (2.8)

 Psoriasis 0 1 (2.8)

HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; SAE, serious adverse event; TEAE, treatment‑emergent adverse event.

CONCLUSIONS
 ◾ HP/TAZ lotion was associated with significant, rapid, and sustained reductions in 
disease severity in a Hispanic population with moderate‑to‑severe psoriasis, with good 
tolerability and safety over 8 weeks of once‑daily use

REFERENCES
1. Nestle FO, et al. N Engl J Med. 2009;361(5):496‑509.
2. Cohen SN, et al. Clin Exp Dermatol. 2012;37 Suppl 1:13‑18.
3. Menter A, et al. J Am Acad Dermatol. 2009;60(4):643‑659.

4. Lam LH, et al. J Drugs Dermatol. 2016; 15(8):945‑948.
5. Sugarman JL, et al. J Drugs Dermatol. 2018;17(8):855‑861.  

AUTHOR DISCLOSURES
AF Alexis has received grants/research support from Almirall, Bristol‑Myers‑Squibb, Celgene, Galderma, LEO, Menlo, Novartis, SkinMedica, and 
Bausch Health; and has served as a consultant for Beiersdorf, Bristol‑Myers‑Squibb, Celgene, Dermavant, Galderma, LEO, L’Oreal, Menlo, Novartis, 
Pfizer, Sanofi‑Regeneron, Scientis, UCB, Unilever, and Bausch Health. PS Yamauchi has served as speaker, consultant, and investigator for AbbVie, 
Amgen, Janssen, Novartis, Lilly, LEO, Ortho Dermatologics, and Sun Pharma. T Lin is an employee of Ortho Dermatologics. G Martin is an employee 
of Bausch Health Americas Inc.

 ◾ Participants treated with HP/TAZ lotion achieved a 40.7% mean reduction from baseline in 
BSA at Week 8 versus a 10.1% increase with vehicle (P=0.002), and a 50.5% mean reduction 
in IGAxBSA score versus an 8.5% increase with vehicle (P<0.001); effects were sustained 
posttreatment (Figure 2)

 ◾ HP/TAZ lotion demonstrated rapid reduction in disease severity, with significant 
improvements versus placebo observed by Week 2 for IGAxBSA reduction and by Week 4 for 
treatment success

FIGURE 1. Percentage of Participants Achieving Treatment Successa by Study Visit 
(ITT Population; Pooled Data)

0%

30%

20%

10%

40%

50%

60%

70%

80%

90%

100%

Study Visit (Weeks)

P
e
rc

e
n
ta

g
e
 o

f 
P

a
rt

ic
ip

a
n
ts

0 2 4 6 8 12

Treatment Posttreatment

HP/TAZ (n=78)
Vehicle (n=37)

* P=0.034 vs vehicle; **P=0.003 vs vehicle; ***P=0.002 vs vehicle; ****P<0.001 vs vehicle.
aTreatment success was defined as ≥2‑grade improvement from baseline in IGA score and a score of ‘clear’ or ‘almost clear’.
HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator Global Assessment; ITT, intent‑to‑treat.

Efficacy, Safety, and Tolerability of a Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination in 
the Treatment of Moderate‑to‑Severe Plaque Psoriasis in a Hispanic Population: 
Post Hoc Analysis of Two Phase 3 Randomized Controlled Trials