Clinical evidence on the efficacy and tolerability of a topical medical device containing benzoylperoxide 4%, retinol 0.5%, mandelic acid 1% and lactobionic acid 1% in the treatment of mild facial acne: an open label pilot study

Abstract

Background: Acne is a debilitating disorder that requires proper treatment depending on the clinical manifestations and pathogenetic factors, among which hyper-keratinization, seborrhea and bacterial proliferation. Combining active ingredients targeting the different mediators of acne pathogenesis may yield optimal outcomes. Purpose: The purpose of this study was to evaluate the clinical effectiveness, safety and tolerability of a new topical medical device in cream containing benzoylperoxide 4%, pure retinol 0.05%, palmitate retinol 0.5%, mandelic acid 1% and glycyrrhetic acid on patients with mild acne. Patients and methods: Twenty consecutive patients of both sexes with mild acne were included in the study. The topical treatment was self-applied twice a day for 12 weeks. Evaluations included: Global Acne Grading System (GAGS); inflammatory and non-inflammatory lesions count; reflectance confocal microscopy; seborrhea and hydration degree; photographic documentation; a questionnaire to assess tolerability. Results: The GAGS score showed a 39% reduction from T0 to T1 and 69.20% from T0 to T2. The count of comedonic lesions showed a 44% reduction from T0 to T1 and 65% from T0 to T2. The count of papular lesions diminished by 49.4% from T0 to T1 and by 62% from T0 to T2. The count of pustular lesions decreased by 43% from T0 to T1 and by 80% from T0 to T2. Improvement of hydration and a decrease of seborrhea degree were even observed. These clinical results were confirmed by reflectance confocal microscopy exam. Conclusion: The topical medical device has shown to be clinically effective and well tolerated for the treatment of mild acne. Side effects were mild, transient and well tolerated. The results of our study demonstrated a high tolerability of this new combination of benzoylperoxide 4% and retinol. Furthermore, our results suggested that the studied compound could be considered as a "maintenance treatment" after specific pharmacological treatment, even in more severe types of acne.

Keywords: acne vulgaris; alpha hydroxide acid; benzoyl peroxide; therapeutics; vitamin A.

Figure 1

Efficacy of the treatment. Clinical evaluation before (A and B) and after 12 weeks of treatment (C and D) .The mean GAGS score decreased significantly over the course of the study period.

Figure 2

(A) A regular decrease in the number of acne lesions was observed during the study. (B) The GAGS score showed a reduction of 39% from T0 to T1 and of 69,20% from T0 to T2. (C) Seborrhea showed a reduction of 15% from T0 to T2. (D) Hydration showed an improvement of 32% from T0 to T2.

Figure 3

Reflectance confocal microscopy (RCM). (A) pustular lesion show inflammation of the follicle with characteristic bright dots inside and around the infundibulum. (B) after treatment, RCM show normal hair follicle with regular non-reflective borders.