Results

The safety, efficacy, and tolerability of EPSOLAY cream were evaluated in two multicenter, randomized, double-blind, parallel-group, vehicle-controlled Phase III trials (NCT03448939 / NCT03564119). Conducted at 54 sites across the United States between June 2018 and June 2019, the trials enrolled 733 adult subjects (≥18 years) with moderate to severe papulopustular rosacea. Subjects were randomized 2:1 to once-daily EPSOLAY cream (n=493) or vehicle cream (n=240), treated for 12 weeks.

Eligible subjects had a baseline IGA (Investigator Global Assessment) score of 3 (moderate) or 4 (severe) and between 15 and 70 inflammatory lesions (papules and/or pustules), with no more than 2 nodules (defined as a papule or pustule >5 mm in diameter). Subjects with a history of ocular rosacea, other facial dermatoses, hypersensitivity or unresponsiveness to BPO, or concurrent use of drugs known to cause acneiform eruptions were excluded. At baseline, subjects had a mean inflammatory lesion count of 27.5; 89% were scored as moderate (IGA=3) and 11% as severe (IGA=4).

A pea-sized amount of study cream was applied as a thin layer to each facial area (forehead, chin, nose, and each cheek) once daily at approximately the same time each day. Following a baseline evaluation on Day 1, subjects returned for post-baseline visits at Weeks 2, 4, 8, and 12. Standardized facial photography was performed at baseline and at each post-baseline visit at selected sites.

The co-primary efficacy endpoints were (1) treatment success at Week 12, defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade reduction from baseline, and (2) absolute change in inflammatory lesion count from baseline to Week 12. Secondary endpoints included percentage change in lesion count from baseline to Week 12, absolute lesion count changes at Weeks 2, 4, and 8, and the proportion of subjects achieving IGA success at those interim visits. The Week 2 endpoints were analyzed as a post-hoc analysis.

Safety was assessed by monitoring adverse events, recording vital signs, and evaluating cutaneous safety (dryness and scaling) and local tolerability (itching and stinging/burning) at baseline and all post-baseline visits. Each parameter was measured on a four-point scale (0=none, 1=mild, 2=moderate, 3=severe).

Investigator Global Assessment (IGA) score scale:

• 0: Clear – Skin clear of inflammatory papules or pustules
• 1: Almost clear – Very few small papules or pustules and very mild, dull erythema is present
• 2: Mild – Few small papules or pustules and mild, dull, or light pink erythema is present
• 3: Moderate – Several to many small or larger papules or pustules and moderately light to bright red erythema is present
• 4: Severe – Numerous small and/or larger papules or pustules and severe erythema that is bright red to deep red are present