2 PHASE 3 TRIALS
Class 1 efficacy at week 8, when applied once daily, with continued results 4 weeks post treatment1,2
†Treatment success defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score as well as a score of "clear" or "almost clear" at week 8 primary endpoint.2
‡The treatment difference at week 2 in trial 2 was not statistically significant.
SEE THE STUDY DESIGN
The safety and efficacy of BRYHALI Lotion were assessed in 2 prospective, multicenter, randomized, double-blind, phase 3 clinical trials in 430 adult patients with moderate-to-severe plaque psoriasis. Patients were treated with BRYHALI Lotion or vehicle lotion, applied once daily. Primary efficacy endpoint was treatment success evaluated at week 8. Secondary efficacy endpoint was treatment success evaluated at weeks 2, 4, 6, and 12 (4 weeks post treatment). Tertiary efficacy endpoint was a 2-grade improvement from baseline at each time point for the individual signs of psoriasis (erythema, plaque elevation, and scaling).2
Significant clearance with less steroid exposure2
- 37.5% of patients had treatment success at week 8 vs 10.0% for vehicle (P<0.001 from trials 1 and 2)
- The only single-agent low-concentration halobetasol (0.01%) formulation
No increased epidermal atrophy observed through 8 weeks of once-daily treatment1,2
- Pooled analysis of 2 phase 3 trials: In both the BRYHALI Lotion and vehicle groups, an average of 0.8% of patients had epidermal atrophy at week 8. All cases were already present at baseline.§
- Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, hypopigmentation and allergic contact dermatitis. Some local adverse reactions may be irreversible.
§In a phase 2 trial, there was 1 case of epidermal atrophy at week 6, which was not reported at weeks 8 and 12.3