EPSOLAY SIDE EFFECTS
- Generic Name: benzoyl peroxide topical cream
- Brand Name: Epsolay
- Drug Class: Acne Agents, Topical
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two randomized, double-blind, vehicle-controlled trials, adult subjects with rosacea applied EPSOLAY (N = 488) or vehicle (N = 234) once daily for 12 weeks. The majority of subjects were Caucasian (93%) and female (73%) with a mean age of 51 years.
Table 1 presents the most common adverse reactions occurring in ≥ 1% of subjects treated with EPSOLAY and more frequently than in subjects treated with vehicle.
Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with EPSOLAY and with Greater Frequency than Subjects Treated with Vehicle
|Application site pain||11 (2%)||2 (1%)|
|Application site erythema||11 (2%)||2 (1%)|
|Application site pruritus||6 (1%)||1 (<1%)|
|Application site edema*||4 (1%)||0 (0%)|
|* Application site edema includes: application site swelling and application site edema|
During the clinical trials, local tolerability evaluations were conducted at baseline and at each study visit by assessment of dryness, itching, scaling and stinging/burning. Table 2 presents the local tolerability assessments by severity grade at Week 12.
Table 2: Facial Cutaneous Tolerability Assessment
|Severity at Week 12|
|* Of the 488 subjects treated with EPSOLAY, 455 subjects had local tolerability assessments at Week 12.|
In a 40-week open-label extension safety study (for a total of up to 52 weeks of treatment) the frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.
SRC: NLM .