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New phase 3 data show a microencapsulated form of the topical antiseptic and vitamin D derivative is beneficial and tolerable over 12 weeks.
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, and other methods.
Del Rosso and colleagues observed significant superiority of microencapsulated BPO plus tretinoin versus vehicle cream in both trials’ primary endpoints. In the first study, nearly 2 in 5 (39.9%) of patients treated with the combination therapy achieved IGA success, versus 14.3% of the vehicle arm. Significantly more treated patients (26.8%) achieved this outcome than the vehicle arm (15.1%) in the second trial as well.
Patients treated with BPO plus tretinoin in the first and second study achieved 21.6 and 16.2 mean inflammatory lesion reductions from baseline, versus 14.8 (P <.001) and 14.1 (P = .018) reductions in the vehicle arms, respectively.
Treated patients additionally reported 29.7 and 24.2 mean reductions in non-inflammatory lesions from baseline in both trials, versus 19.8 (P <.001) and 17.4 (P <.001) in the vehicle arms, respectively.
Investigators reported good tolerability with the combination therapy in both studies, with the most commonly reported adverse events being application site pain (10.6%), dryness (4.9%) and exfoliation (4.1%).
They concluded that encapsulated benzoyl peroxide plus tretinoin was an effective and safe fixed-dose regimen among patients with moderate to severe acne.
“Treatment…provided statistically significant improvements in IGA scores and reduced both inflammatory and non-inflammatory lesions in subjects with moderate to severe acne,” investigators wrote. “The study met all primary endpoints and demonstrated significant improvement over vehicle at 12 weeks, with no treatment-related serious adverse events.”
The study, “A New Frontier in Acne Treatment: Encapsulated Benzoyl Peroxide and Tretinoin,” was published online in JDPA.