Safety and Efficacy of a Once-Daily Halobetasol Propionate 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results of Two Phase 3 Randomized Controlled Trials.

Abstract

BACKGROUND:

Topical corticosteroids (TCS) are the mainstay of psoriasis treatment; long-term safety concerns limiting consecutive use of potent TCS to 2-4 weeks.

OBJECTIVE:

Investigate safety and efficacy of halobetasol propionate 0.01% lotion in moderate-to-severe plaque psoriasis.

METHODS:

Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in Investigator Global Assessment [IGA] score and 'clear' or 'almost clear') at week 8. Safety and treatment emergent adverse events (AEs) evaluated throughout.

RESULTS:

Halobetasol propionate 0.01% lotion demonstrated statistically significant superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on vehicle (P less than 0.001). Halobetasol propionate 0.01% lotion was also superior in reducing psoriasis signs and symptoms, body surface area (BSA), and improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated with no treatment-related AEs greater than 1%.

LIMITATIONS:

Study did not include subjects with BSA greater than 12.

CONCLUSIONS:

Halobetasol propionate 0.01% lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, without the safety concerns of a longer treatment course. J Drugs Dermatol. 2018;17(10):1062-1069.

• Authors: Lawrence J Green, Francisco A Kerdel, Fran E Cook-Bolden, Jerry Bagel, Tina Lin, Gina Martin, Radhakrishnan Pillai, Robert Israel, Tage Ramakrishna
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 17 Issue 10 Pg. 1062-1069 (Oct 01 2018) ISSN: 1545-9616 [Print] United States
• PMID: 30365586 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Dermatologic Agents
• halobetasol
• Clobetasol

Topics

• Administration, Cutaneous
• Clobetasol (administration & dosage, analogs & derivatives, therapeutic use)
• Dermatologic Agents (administration & dosage, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Male
• Middle Aged
• Psoriasis (drug therapy, pathology)
• Randomized Controlled Trials as Topic
• Severity of Illness Index
• Skin Cream
• Treatment Outcome
• United States