Safety & satisfaction
With the controlled release of BPO through microencapsulation technology, EPSOLAY cream has a delicate touch.
EPSOLAY cream was well tolerated by patients with sensitive rosacea skin1
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
Adverse reactions reported by ≥1% of patients in the 12-week pivotal trials treated with EPSOLAY cream and more frequently than with vehicle cream (all on application site)1
Mean tolerability parameters of EPSOLAY and vehicle stayed below 1 on a scale of 0 to 3 and were not statistically different1,2
EPSOLAY cream has a delicate touch, making it suitable for long-term use1,3
In the long-term, open-label study involving 547 patients, <1% of patients discontinued participation due to adverse reactions.3
The long-term safety and tolerability of daily use of EPSOLAY cream were evaluated in an open-label, long-term safety study in papulopustular rosacea patients from the 2 double-blind pivotal trials. A total of 547 patients were enrolled, including 363 patients previously treated with EPSOLAY cream and 184 patients previously treated with vehicle cream.
Patients were treated with EPSOLAY cream once daily from baseline through Week 40 with an IGA score for rosacea assessed as mild, moderate, or severe. If a patient was assessed as clear or almost clear, patients were not dispensed the study product until relapse was assessed.
Patients were required to have completed 12 weeks or be within the Week 12 window time (±4 days) of the double-blind treatment period of the pivotal trials.
At baseline, patients had a mean inflammatory lesion count of 28.4, 89.2% were scored as moderate (IGA=3), and 10.8% were scored as severe (IGA=4).
Safety was evaluated by monitoring adverse events, cutaneous safety (dryness and scaling), and local tolerability (itching and burning/stinging) assessments, physical examinations, and vital signs. The study was not intended to assess efficacy. Certain efficacy data and endpoints were, however, summarized.
Facial cutaneous tolerability assessment by severity at Week 523
Rosacea relief patients can see
Using EPSOLAY cream led to nearly 70% reduction in inflammatory lesions by Week 12.1
References:
- EPSOLAY (benzoyl peroxide) cream, 5% [prescribing information]. Raleigh (NC): Mayne Pharma; revised 2025 Feb.
- Bhatia N, Werschler WP, Baldwin H, Sugarman J, Green LJ, Levy-Hacham O, et al. Efficacy and safety of microencapsulated benzoyl peroxide cream, 5%, in rosacea: results from two phase III, randomized, vehicle-controlled trials. J Clin Aesthet Dermatol. 2023;16(8):34-40.
- Werschler WP, Sugarman J, Bhatia N, Baldwin H, Stein Gold L, Green LJ, et al. Long-term efficacy and safety of microencapsulated benzoyl peroxide cream, 5%, in rosacea: results from an extension of two phase III, vehicle-controlled trials. J Clin Aesthet Dermatol. 2023;16(8):27-33.
Important Safety Information
Indications and usage: EPSOLAY® (benzoyl peroxide) cream, 5% is indicated for the treatment of inflammatory lesions of rosacea in adults.
Contraindications: A history of hypersensitivity reactions to benzoyl peroxide or any component of the formulation in EPSOLAY.
Warnings and precautions:
- Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with the use of benzoyl peroxide products.
- Skin irritation/contact dermatitis: Erythema, scaling, dryness, stinging/burning, irritation and allergic contact dermatitis may occur with the use of EPSOLAY and may necessitate discontinuation.
- Photosensitivity: Avoid or minimize exposure to natural or artificial sunlight and use sun protection measures.
Adverse reactions: Most common adverse reactions (incidence ≥1%) are application site reactions: pain erythema, pruritus, and edema.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.