Multicenter study for efficacy and safety evaluation of a fixeddose combination gel with adapalen 0.1% and benzoyl peroxide 2.5% (Epiduo® for the treatment of acne vulgaris in Brazilian population

Abstract

BACKGROUNDThe current options for the treatment of acne vulgaris present many mechanisms of action. For several times, dermatologists try topical agents combinations, looking for better results.OBJECTIVESTo evaluate the efficacy, tolerability and safety of a topical, fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% gel for the treatment of acne vulgaris in the Brazilian population.METHODSThis is a multicenter, open-label and interventionist study. Patients applied 1.0 g of the fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% gel on the face, once daily at bedtime, during 12 weeks. Lesions were counted in all of the appointments, and the degree of acne severity, overall improvement, tolerability and safety were evaluated in each visit.RESULTSFrom 79 recruited patients, 73 concluded the study. There was significant, fast and progressive reduction of non-inflammatory, inflammatory and total number of lesions. At the end of the study, 75.3% of patients had a reduction of >50% in non-inflammatory lesions, 69.9% in inflammatory lesions and 78.1% in total number of lesions. Of the 73 patients, 71.2% had good to excellent response and 87.6% had satisfactory to good response. In the first week of treatment, erythema, burning, scaling and dryness of the skin were frequent complaints, but, from second week on, these signals and symptoms have reduced.CONCLUSIONThe fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% gel is effective, safe, well tolerated and apparently improves patient compliance with the treatment.

The effectiveness of adapalene 0.1% with intense pulsed light versus benzoyl peroxide 5% with intense pulsed light in the treatment of acne vulgaris: A comparative study

“…showed that the AD and BPO treatments were helpful in ameliorating AV and less expensive than other treatments. [3132] Our study shows the same effects in two groups which is in accordance with the discussed articles.…”

Topical benzoyl peroxide application on the shoulder reduces Propionibacterium acnes : a randomized study

“…These side effects appear in the beginning 14,27 of treatment and may be a drawback in general treatment with BPO in conjunction with shoulder surgery.…”

Clinical efficacy of 0.5% topical mangosteen extract in nanoparticle loaded gel in treatment of mild‐to‐moderate acne vulgaris: A 12‐week, split‐face, double‐blinded, randomized, controlled trial

“…The results of MNLG were significantly comparable to 1% clindamycin‐treated side which also significantly reduced the comedone and inflammatory acne lesions up to 55.33% and 64.16%, respectively. Distinctively, the efficacy of MNLG application with 2.5% BPO in this study was comparable to the standard combination treatment of 0.1% adapalene and 2.5% BPO, with the decreasing of both comedone lesions (73%) and inflammatory acne lesions (73.9%) over the 12 weeks of treatment . However, the efficacy could be the synergistic effect of BPO and MNLG, because the BPO monotherapy also showed the efficacy in the treatment of acne with the median reduction of 55.6% and 44.1% in inflammatory lesion and noninflammatory lesions count after 12‐week treatment, respectively…”