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

 ◾ Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression1 

 ◾ Although plaque psoriasis can occur across different body regions, the lower extremities are one of 
the most commonly affected areas2 

 ◾ Topical corticosteroids are the mainstay of psoriasis treatment; however, safety concerns limit their 
use3

 ◾ Recent phase 3 clinical data demonstrated the efficacy and tolerability of a fixed combination 
lotion containing halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ; Duobrii® Ortho 
Dermatologics, Bridgewater, NJ) in patients with moderate-to-severe localized plaque psoriasis4,5 

OBJECTIVE

 ◾ To evaluate the efficacy and safety of HP/TAZ lotion in participants where the leg was identified as 
the target lesion 

METHODS

 ◾ In two phase 3, multicenter, randomized, double-blind studies (NCT02462070; NCT02462122), 
participants with moderate-to-severe plaque psoriasis were randomized (2:1) to receive  
HP/TAZ lotion or vehicle lotion once-daily for 8 weeks, with a 4-week posttreatment follow-up4,5

• At baseline, participants were required to have an Investigator Global Assessment (IGA) score of 
moderate (3) or severe (4) and Body Surface Area (BSA) of 3% to 12%

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

 ◾ A pooled, post hoc analysis was conducted in a subset of participants with plaque psoriasis of the 
lower extremities, with a target lesion of the leg

• For the target lesion, participants needed a score of ≥3 for at least 2 of 3 signs of psoriasis 
(erythema, plaque elevation, scaling: each on a 5-point scale; 0=clear and 4=severe), a sum of at 
least 8, and could not have a score 0 or 1 in any one of the signs

• Target could not be on areas covering bony prominences (i.e., knees); however, overall psoriasis 
assessment (IGA and BSA) did not exclude the knees

 ◾ Efficacy assessments included: treatment success (≥2-grade improvement from baseline) in each 
individual sign of psoriasis (erythema, plaque elevation, and scaling) at the target lesion (leg); 
overall treatment success (≥2-grade improvement from baseline in IGA score and a score of ‘clear’ 
or ‘almost clear’ [0 or 1]); improvements in overall mean BSA from baseline; and mean change 
from baseline in IGAxBSA composite score

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

RESULTS

Participants

 ◾ This analysis included 219 participants where the leg was identified as the target lesion  
(HP/TAZ lotion, n=148; vehicle, n=71)

Efficacy

 ◾ At the end of the 8-week treatment period, significantly more HP/TAZ-treated participants achieved 
≥2-grade reduction in erythema, plaque elevation, and scaling compared with vehicle-treated 
participants; significant differences between HP/TAZ and vehicle were observed as early as week 2 and 
sustained posttreatment (Figure 1)

Efficacy and Safety of Halobetasol Propionate 0.01%/Tazarotene 0.045% (HP/TAZ) Lotion in the  
Treatment of Moderate to Severe Plaque Psoriasis of the Lower Extremities

FIGURE 2. Overall Treatment Successa by Study Visit in Participants With a Target Lesion 
on the Leg (ITT Population, Pooled)

50%

60%

70%

40%

30%

20%

10%

0%

0 2 4 6 8 12

P
e
rc

e
n
ta

g
e
 o

f 
 P

a
rt

ic
ip

a
n
ts

Treatment Posttreatment

7.7%

22.5%

33.5%
35.3%

10.9%

1.4%
5.7%

8.9% 10.4%

36.4%

Study Visit (Weeks)

HP/TAZ Lotion (n=148)
Vehicle (n=71)

** P<0.01 vs vehicle; *** P<0.001 vs vehicle.
aTreatment success is defined as a ≥2-grade improvement from baseline in IGA score and a score of ‘clear’ or ‘almost clear’ (0 or 1).
HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; IGA, Investigator Global Assessment; ITT, intent-to-treat.

FIGURE 3. Mean Percent Reduction in Overall Affected Body Surface Area (BSA) by Study 
Visit in Participants With a Target Lesion on the Leg (ITT Population, Pooled)

-10%

0%

10%

-20%

-30%

-40%

0 2 4 6 8 12

P
e
rc

e
n
t 
C

h
a
n
g

e
 f
ro

m
 B

a
se

li
n
e

Treatment Posttreatment

-5.6%

-18.7%

-25.9%

-34.8%

7.3%

3.1% 3.2%

-0.9% -1.0%

-32.7%

Study Visit (Weeks)

HP/TAZ Lotion (n=148)
Vehicle (n=71)

* P<0.05 vs vehicle; *** P<0.001 vs vehicle.
HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; ITT, intent-to-treat.

FIGURE 4. Mean Percent Reduction in IGAxBSA Composite by Study Visit in Participants 
With a Target Lesion on the Leg (ITT Population, Pooled) 

-10%

0%

10%

-20%

-30%

-50%

-40%

-60%

0 2 4 6 8 12

P
e
rc

e
n
t 
C

h
a
n
g

e
 f
ro

m
 B

a
se

li
n
e

Treatment Posttreatment

-24.1%

-35.7%

-43.5%
-47.2%

-8.5%
-3.0% -2.6% -4.8% -4.5%

-47.3%

Study Visit (Weeks)

HP/TAZ Lotion (n=148)
Vehicle (n=71)

*** 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.

Safety

 ◾ The most frequently reported treatment-related TEAEs were contact dermatitis, skin atrophy, folliculitis, 
and excoriation; 11 participants treated with HP/TAZ lotion discontinued due to TEAEs (Table 1)

TABLE 1. Treatment-Emergent Adverse Events Through Week 8 in Participants With a 
Target Lesion on the Leg (Safety Population, Pooled)

Participants, n (%)
HP/TAZ Lotion

(n=144)
Vehicle
(n=70)

Reporting any TEAEs 52 (36.1) 16 (22.9)
Reporting any SAEs 3 (2.1) 0
Discontinued due to TEAEs 11 (7.6) 4 (5.7)
Severity of TEAEs reported

Mild 10 (6.9) 3 (4.3)

Moderate 29 (20.1) 9 (12.9)

Severe 13 (9.0) 4 (5.7)

Relationship to study drug
Related 34 (23.6) 7 (10.0)

Unrelated 18 (12.5) 9 (12.9)

Treatment-related TEAEs reported in ≥2% of participants
Contact dermatitis 11 (9.0) 0

Skin atrophy 4 (2.8) 0

Folliculitis 4 (2.8) 0

Excoriation 3 (2.1) 0

Pruritis 2 (1.4) 2 (2.9)

Skin burning sensation 2 (1.4) 2 (2.9)

Burning sensation (nervous system disorders) 2 (1.4) 2 (2.9)

AE, adverse event; 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 patients with moderate-to-severe psoriasis where the leg was identified as the 
target lesion, 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. Augustin M, et al. Br J Dermatol. 2019;181(2):358-365. 
3. Lam LH, et al. J Drugs Dermatol. 2016;15(8):945-948.
4. Stein Gold L, et al. J Am Acad Dermatol. 2018;79(2):287-293.
5. Sugarman JL, et al. J Drugs Dermatol. 2018;17(8):855-861.

AUTHOR DISCLOSURES
Stephen K. Tyring is has acted as an investigator for Ortho Dermatologics.
Leon H. Kircik has acted as an investigator, advisor, speaker, and consultant for Ortho Dermatologics.
Paul S. Yamauchi has served as speaker, consultant, and investigator for AbbVie, Amgen, Janssen, Novartis, Lilly, LEO, Ortho Dermatologics, and 
Sun Pharma.
Naveen Anbalagan and Tina Lin are employees of Ortho Dermatologics and may hold stock and/or stock options in its parent company.

FIGURE 1. Treatment Successa in Psoriasis Signs of Erythema (A), Plaque Elevation (B), and 
Scaling (C) at the Leg Target Lesion by Study Visit (ITT Population, Pooled)

50%

60%

70%

40%

30%

20%

10%

0%

0 2 4 6 8 12

50%

60%

70%

40%

30%

20%

10%

0%

0 2 4 6 8 12

50%

60%

70%

40%

30%

20%

10%

0%

0 2 4 6 8 12

12

12

12

P
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a
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A. Erythema

Treatment Posttreatment

14.1%

28.4%

36.2%

44.6%

17.3%

1.5%

7.2%
9.4%

12.5%

41.6%

P
e
rc

e
n
ta

g
e
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f 
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a
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ic
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a
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B. Plaque Elevation

Treatment Posttreatment

27.8%

44.0%

52.3% 53.2%

27.9%

11.3% 10.1%

17.8% 19.2%

58.5%

P
e
rc

e
n
ta

g
e
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f 
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a
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ic
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a
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C. Scaling
Treatment Posttreatment

31.1%

48.7%

54.1% 54.4%

26.0%

5.7%
10.4%

17.6%
21.0%

59.5%

Study Visit (Weeks)

HP/TAZ Lotion (n=148)
Vehicle (n=71)

Study Visit (Weeks)

HP/TAZ Lotion (n=148)
Vehicle (n=71)

Study Visit (Weeks)

HP/TAZ Lotion (n=148)
Vehicle (n=71)

** P<0.01 vs vehicle; *** P<0.001 vs vehicle.
aTreatment success is defined as a ≥2-grade improvement from baseline in each individual sign of psoriasis at the target lesion.
HP/TAZ, halobetasol propionate 0.01% and tazarotene 0.045%; ITT, intent-to-treat.

 ◾ Significantly more participants achieved overall treatment success (per IGA scores) at week 8 with  
HP/TAZ compared with vehicle (Figure 2)

 ◾ The HP/TAZ group also had a significantly greater mean percent reduction in BSA at week 8 
versus vehicle (Figure 3)

 ◾ Change from baseline in IGAxBSA composite score was significantly improved with HP/TAZ lotion 
versus vehicle at all study visits assessed (Figure 4)

Stephen K Tyring, MD, PhD1; Leon H Kircik, MD2; Paul S Yamauchi, MD, PhD3; Naveen Anbalagan, MD4; Tina Lin, PharmD4
1University of Texas Health Science Center, Houston, TX; 2Indiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; and Icahn School of Medicine at Mount Sinai, New York, NY; 3Dermatology Institute & Skin Care Center, Inc., Santa Monica, CA; 4Ortho Dermatologics*, Bridgewater, NJ
*Ortho Dermatologics is a division of Bausch Health US, LLC.