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

Background: The 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.

Objectives: To 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.

Methods: This 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.

Results: From 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.

Conclusion: The 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.

1A

Box-plots (chart on the left) and percentage of median change from baseline (chart on the right) in the number of noninflammatory lesions

1B

Box-plots (chart on the left) and percentage of median change from baseline (chart on the right) in the number of inflammatory lesions.

1C

Box-plots (chart on the left) and percentage of median change from baseline (chart on the right) in the number of total lesions * Statistically significant differences when compared with results at week 0 ** Statistically significant differences when compared with results at week 0 and 1. *** Statistically significant differences when compared to results from week 0 to 2 . **** Statistically significant differences when compared to results from week 0 to 4 (Friedman; p < 0.001).

Figure 2

Evolution of the severity of acne (distribution of patients in percentage) in weeks of treatment Facial acne severity was eva;uated fpllowing the scale below: 0 No lesions, just presenting erythema or residual hyperpigmentation 1 Presence of a few comedones and a few small papules and pustules 2 Presence of some comedones, papules and pustules. No nodule present 3 Presence of many comedones, papules and pustules. One nodule may be present 4 Covered with comedones, numerous papules and pustules. Presence of few nodules and cysts 5 Highly infammatory acne covering the face, with nodules and cysts present * Statistically significant differences when compared with results at week 0. ** Statistically significant differences when compared with results at week 0 and 1. *** Statistically significant differences when compared with results from week 0 to 2 . **** Statistically significant differences when compared with results from week 0 to 4 (Friedman; p <0.001)

Figure 3A

Erythema evaluation

Figure 3B

Burning evaluation

Figure 3C

Dryness evaluation

Figure 3D

Scaling evaluation

Figure 4

Patient photographed at baseline and at week 12 after initiation of treatment

Figure 5

Patient photographed at baseline and at 12 weeks after initiation of treatment

Figure 6

Patient photographed at baseline and at 12 weeks after initiation of treatment