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 varies widely in its clinical expression1

 ◾ Topical corticosteroids are the mainstay of treatment in psoriasis, but long-term safety remains a 
concern, limiting use, and posttreatment flare-up is common2

 ◾ While psoriasis commonly affects lower extremities, treatment can be more problematic, and 
burden of disease heightened3,4

 ◾ Recent phase 3 clinical data have demonstrated that halobetasol propionate (HP) 0.01% lotion 
(ByhaliTM Ortho Dermatologics, Bridgewater, NJ) was significantly more effective than vehicle after 8 
weeks of treatment in patients with moderate-to-severe localized plaque psoriasis,5,6 though efficacy 
in specific locations has not been reported

OBJECTIVE
 ◾ To investigate the efficacy of once-daily HP 0.01% lotion versus vehicle in patients with moderate-
to-severe plaque psoriasis of the lower extremities

METHODS

Study Design

 ◾ Data from two phase 3, multicenter, randomized, double-blind studies of patients with moderate-
to-severe psoriasis were pooled5,6

 ◾ Participants were randomized (2:1) to receive HP 0.01% lotion or vehicle once-daily for 8 weeks, 
with a 4-week posttreatment follow-up

 ◾ At baseline, participants were required to have Investigator Global Assessment (IGA) score of 3 or 4 
(5-point scale; 0=clear and 4=severe) and Body Surface Area (BSA) of 3% to 12%

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

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

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

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

Efficacy Assessments

 ◾ 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

Halobetasol 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis of the Lower Extremities

Neal D Bhatia, MD1; Tracey C Vlahovic, DPM2; Lawrence Green, MD3; Gina Martin, MOT4; Tina Lin, PharmD5
1Therapeutics Clinical Research, San Diego, CA; 2Temple University School of Podiatric Medicine, Philadelphia, PA; 3Department of Dermatology, George Washington University School of Medicine, Washington, DC; 4Bausch Health Americas, Inc., Petaluma, CA; 5Ortho Dermatologics, Bridgewater, NJ

 ◾ Reductions of ≥50% and ≥75% of overall IGAxBSA from baseline (IGAxBSA-50 and IGAxBSA-75) at 
Week 8

 ◾ Quality of life (QoL) with 10 question Dermatology Life Quality Index (DLQI; 4-point scale; 0=not at 
all/not relevant and 3=very much)

• Mean change in DLQI of 4 was considered a minimal clinically important difference (MCID)7

RESULTS

 ◾ This analysis included 234 patients where leg was identified as the target lesion (HP 0.01% lotion, 
n=151; vehicle, n=83)

 ◾ At the end of the 8-week treatment period, more than half of participants receiving HP 0.01% lotion 
achieved treatment success at the target lesion, with 52.1%, 55.5%, and 58.2% achieving ≥2-grade 
reduction in erythema, plaque elevation, and scaling severity on the leg, compared with 15.7%, 
22.9% and 22.2% of those treated with vehicle, respectively (P<0.001 all; Figure 1)

FIGURE 1: Treatment Successa in Psoriasis Signs of (A) Erythema, (B) Plaque Elevation, 
and (C) Scaling

0%

30%

20%

10%

40%

50%

60%

70%

Study Visit (Weeks)

P
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0 2 4 6 8

A. Erythema

Halobetasol propionate 0.01% lotion (n=151)
Vehicle (n=83)

0%

30%

20%

10%

40%

50%

60%

70%

Study Visit (Weeks)

P
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0 2 4 6 8

B. Plaque Elevation

Halobetasol propionate 0.01% lotion (n=151)
Vehicle (n=83)

0%

30%

20%

10%

40%

50%

60%

70%

Study Visit (Weeks)

P
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0 2 4 6 8

C. Scaling

Halobetasol propionate 0.01% lotion (n=151)
Vehicle (n=83)

*P<0.01 versus vehicle; **P<0.001 versus vehicle.  
aDefined as a ≥2-grade improvement from baseline in each individual sign of psoriasis (erythema, plaque elevation, and scaling) at the target lesion (leg).

 ◾ Figure 2 illustrates treatment success with HP 0.01% lotion in the leg target lesion

FIGURE 2: Improvement of Psoriasis with Once-Daily Halobetasol Propionate 0.01% Lotion

 ◾ Overall treatment success per IGA was achieved in 37.1% of participants treated with HP 0.01% 
lotion compared with 8.4% treated with vehicle (P<0.001; Figure 3) 

FIGURE 3: Overall Treatment Successa on IGA Assessment of Disease Severity

0%

30%

20%

10%

40%

50%

60%

70%

Study Visit (Weeks)

P
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ag
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o
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P
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p
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ts

0 2 4 6 8

Halobetasol propionate 0.01% lotion (n=151)
Vehicle (n=83)

 **P<0.001 versus vehicle.  
aDefined as a ≥2-grade improvement from baseline in IGA score and a score of ‘clear’ or ‘almost clear’ [0 or 1]. 
IGA, Investigator Global Assessment.

 ◾ HP-treated patients had a 34.2% mean reduction from baseline in overall BSA compared with a 
3.7% reduction in vehicle-treated patients (P<0.001; Figure 4)

FIGURE 4: Mean Percent Reduction in Overall Body Surface Area (BSA)

-50%

-20%

-30%

-40%

-10%

0%

10%

Study Visit (Weeks)

P
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 R
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uc
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Fr
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m
 B

as
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in
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0 2 4 6 8

Halobetasol propionate 0.01% lotion (n=151)
Vehicle (n=83)

 **P≤0.001 versus vehicle.

 ◾ Mean percent reduction from baseline to Week 8 in IGAxBSA score was also significantly greater 
with HP treatment (-50.5%) than with vehicle (-13.8%; P<0.001)

 ◾ A clinically meaningful effect in overall psoriasis treatment (IGAxBSA-75) was achieved by 37.7% of 
participants treated with HP 0.01% lotion compared with 7.2% treated with vehicle (P<0.001; 
Figure 5)

FIGURE 5: Achievement of ≥50% (IGAxBSA-50) and ≥75% (IGAxBSA-75) Reduction in 
IGAxBSA by Week 8

0%

30%

20%

10%

40%

50%

60%

Halobetasol propionate 0.01% lotion

P
er

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P
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Vehicle

IGAxBSA-50       IGAxBSA-75

**P≤0.001 versus vehicle. 
BSA, body surface area; IGA, Investigator Global Assessment.

 ◾ A clinically relevant improvement in QoL was achieved by Week 4 with HP treatment (DLQI mean 
change of -4.5 vs -3.3; P=0.003) and was maintained at Week 8 (DLQI mean change of -5.5 vs -3.8; 
P<0.001 vs vehicle)

CONCLUSION
 ◾ Halobetasol propionate 0.01% lotion provided significant efficacy versus vehicle 
and clinically relevant improvements in QoL following 8 weeks of therapy in 
patients where the leg was identified as the target lesion

REFERENCES
1. Nestle FO, et al. N Engl J Med. 2009;361(5):496-509.

2. Lam LH and Sugarman JL. J Drugs Dermatol. 2016;15(8):945-948.

3. Blauvet A, et al. J Dermatolog Treat. 2018;29(3):220-229.

4. Armstrong AW, et al. Am J Clin Dermatol. 2016;17:691-699.

5. Sugarman JL, et al. Cutis. 2019;103(2):11-116.

6. Green LJ, et al. J Drugs Dermatol. 2018;17(10):1062-1069.

7. Bernhard J, et al. J Am Acad Dermatol. 1991;25:1170-1174. 

AUTHOR DISCLOSURES
Dr. Neal Bhatia has received honoraria from Ferndale Laboratories, Inc., Promius Pharma, LLC, Novartis, Allergan, Biofrontera AG, IntraDerm Pharmaceuticals, Almirall, Sun 
Pharmaceutical Industries, La Roche-Posay, Mayne Pharma Group, Ortho Dermatologics, Pierre Fabre Dermo-Cosmétique US, ISDIN, Galderma Laboratories, Skinfix, Inc., and 
grants/research funding from Aclaris Therapeutics, Inc., Asana Biosciences, LLC, Crown Laboratories, Inc., LEO Pharma US, DUSA Pharmaceuticals, Inc., Menlo Therapeutics, Par 
Pharmaceutical, Pfizer Inc., Perrigo Company, Realm Therapeutics, Sienna Biopharmaceuticals, Sol-Gel technologies, Soligenix, Inc., Strata Skin Sciences, Vidac Pharma, Brickell 
Biotech, Inc., Dermira, Glenmark Generics Inc., Sanofi/Regeneron, Actavis, BioPharmX, Foamix, Cutanea Life Sciences, MC2 Therapeutics, UCB, AbbVie, Atacama Therapeutics, 
Naked Biome Inc., Kiniksa Pharmaceuticals,  Ltd., BMS, Dr. Reddy, and Vypome (Pending). Dr. Tracey C Vlahovic has served as investigator for Ortho Dermatologics. Dr. Lawrence 
Green has served as consultant, speaker, and/or investigator for Almirall, Cassiopea, Ortho Dermatologics, Sol Gel, and Sun Pharmaceuticals. Ms. Gina Martin is an employee of 
Bausch Health Americas, Inc. Dr. Tina Lin is an employee of Ortho Dermatologics.

Baseline Week 2 Week 4 Week 6 Week 8