A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis

Abstract

Background: Halobetasol propionate (HP) 0.05% is a highly effective short-term treatment for plaque psoriasis.

Objective: Compare efficacy and safety of once-daily HP 0.01% lotion and 0.05% cream (Ultravate^®) in moderate-to-severe psoriasis.

Methods: Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study (N = 150). Patients randomized to HP 0.01% lotion, HP 0.05% cream, or vehicle, once-daily for 2 weeks. Efficacy assessments included treatment success; impact on erythema, plaque elevation, and scaling; and improvement in body surface area (BSA). Safety and treatment-emergent adverse events (TEAEs) were evaluated throughout.

Results: 30.0% and 31.6% of patients were treatment successes with HP 0.01% lotion and HP 0.05% cream (p = .854). A 2-grade improvement in erythema, plaque elevation and scaling was achieved in 38.3%, 40.0%, and 43.3% of patients, compared with 31.6% (p = .446), 36.8% (p = .727), and 47.4% (p = .663) on HP 0.05% cream. BSA improved by 22.3% with HP 0.01% lotion compared with 20.9% (p = .787). There was one treatment-related application-site reaction with HP 0.01% lotion, and no AE reports of skin atrophy, striae, telangiectasia, or folliculitis.

Conclusions: Halobetasol propionate 0.01% lotion was comparable to the higher concentration halobetasol propionate 0.05% cream; achieving treatment success, reducing psoriasis signs at the target lesion, and improving BSA following two weeks’ daily-treatment. Both treatments were well-tolerated.

Clinical Trials Registration: clinicaltrials.gov NCT02785185

Keywords:

• Psoriasis
• topical
• halobetasol
• clinical trial

Acknowledgments

We thank Brian Bulley, MSc (Konic Limited, UK) for assistance with the preparation of the manuscript. Ortho Dermatologics, funded Konic’s activities pertaining to this manuscript.

Institutional review board (IRB) approval

The study protocol, informed consent form, other information provided to subjects, and all appropriate amendments were properly reviewed and approved by Schulman Associates IRB, Inc., Cincinnati, OH 45242.

Disclosure statement

Dr Kerdel, Draelos and Tyring were principal study investigators. Tina Lin and Radhakrishnan Pillai are employees of Bausch Health.

Additional information

Funding

The studies were funded by Dow Pharmaceutical Sciences, Inc.