Encapsulated benzoyl peroxide and tretinoin may provide benefit to clinician scores for inflammatory and non-inflammatory acne lesions in patients over 12 weeks.
New data from a team of US-based investigators suggest the encapsulated combination of topical antiseptic benzoyl peroxide and vitamin A derivative tretinoin provides effective, safe and tolerable benefit as a fixed-dose regimen for patients with moderate to severe acne.
Led by James Q. Del Rosso, DO, of JDR Research, investigators sought efficacy and safety outcomes from a pair of phase 3 trials including fixed-dose 3.0 mg benzoyl peroxide cream plus microencapsulated tretinoin 0.1%. They noted that previous trials have shown the benefit of such a combination in treating acne vulgaris—albeit without silica microencapsulation.
“Benzoyl peroxide (BPO) degrades tretinoin through a process of oxidative decompensation,” investigators wrote. “Treatment with benzoyl peroxide and tretinoin can also result in significant skin irritation, and there is evidence suggesting that their irritative effects may be additive.”
The silica micro encapsulation allows benzoyl peroxide from degrading the vitamin A derivative and allow a controlled release of both beneficial agents to patients’ skin with improved tolerability.
Their 2 multicenter, double-blind, parallel-group, vehicle-controlled assessments included 859 participants aged ≥9 years old with moderate to severe acne. Patients were randomized 2:1 to either once-daily BPO plus tretinoin or vehicle cream for 12 weeks.
Investigators sought co-primary endpoints. The first was proportion of participants achieving ≥2 grade reduction and Clear (0) or Almost Clear (1) scores from Investigator Global Assessment (IGA) scores at week 12 from baseline. The second was absolute change in inflammatory and non-inflammatory lesion counts at week 12 to baseline. They additionally sought safety and tolerability outcomes through adverse event reporting, physical examination,…