Efficacy and Tolerability of Bioinovative Adapalene (Micronised) 0.1% Plus Benzoyl Peroxide (Microencapsulated) 2.5% in Acne Management

Abstract

BACKGROUND Acne vulgaris is a universal skin disease affecting both genders. Acne affects more than 85% of the teenagers as well as some adults and persists in large number of people in their 20s and 30s age. A single-center clinic-based study from a teaching hospital in India reported prevalence of acne among boys and girls between 12-17 years of age as 50.6% and 38.13%, respectively. Combination therapy is an effective approach in the management of acne as it can simultaneously act on several pathogenic mechanisms. The current (2016) European Dermatology Forum (EDF) guidelines recommend combination therapy for all grades of acne as initial treatment. The aim of the study is to evaluate efficacy, safety and patient satisfaction of a bioinnovative fixed-dose combination of adapalene (micronised) 0.1% plus benzoyl peroxide (microencapsulated) 2.5% gel in the treatment of acne. MATERIALS AND METHODS In this prospective survey, acne patients treated with adapalene (micronised) 0.1% plus benzoyl peroxide (microencapsulated) 2.5% for four weeks were enrolled. Grade of acne, investigator global assessment and patient satisfaction scores were noted at baseline, week 2 and week 4. Safety was assessed by recording adverse events and incidence of dryness, erythema or irritation. Global adverse event score was calculated by adding the number of adverse events at week 2 and 4. RESULTS A total of 412 patients with mean duration of acne was 6.98 (5.81) months were enrolled. Number of patients with grade 3 or 4 acne reduced from 202 (49%) at baseline to 73 (17.7%) at week 2 and 31 (7.5%) at week 4, whereas number of patients with grade 1 acne increased from 27 (6.6%) at baseline to 155 (37.6%) after 2 weeks and 277 (67.2%) at 4 weeks (p=0.001, both at 2 and 4 weeks). Number of patients with severe acne reduced from 47 (11.4%) at baseline to 17 (4.1%) after week 2 and 8 (1.9%) after 4 weeks. The improvement in investigator global assessment after treatment at 2 and 4 weeks was statistically significant (p=0.001). After 4 weeks of treatment, 374 (95.6%) patients were either satisfied or more than satisfied. Mean global adverse event score reduced from 2.35 (±2.27) at week 2 to 1.68 (±1.88) after 4 weeks with 28.5% in mean global adverse event score (p=0.001). CONCLUSION Technologically-enhanced formulation of adapalene (micronised) 0.1% plus benzoyl peroxide (microencapsulated) 2.5% is significantly effective and very well tolerated in patients with acne.