A Randomized, Double-Blind, Placebo-Controlled, Multicentric Study to Evaluate the Efficacy and the Tolerability of a Class II Medical Device in the Treatment of Mild and Moderate Acne

Gabriella Fabbrocini; Maria Ferrillo; Marianna Donnarumma; Angela Papale; Daniela Pinto; Fabio Rinaldi

doi:10.1007/s13555-022-00767-1

A Randomized, Double-Blind, Placebo-Controlled, Multicentric Study to Evaluate the Efficacy and the Tolerability of a Class II Medical Device in the Treatment of Mild and Moderate Acne

Dermatol Ther (Heidelb). 2022 Aug;12(8):1835-1845. doi: 10.1007/s13555-022-00767-1. Epub 2022 Jul 21.

Authors

Gabriella Fabbrocini¹, Maria Ferrillo¹, Marianna Donnarumma¹, Angela Papale², Daniela Pinto², Fabio Rinaldi³

Affiliations

¹ Department of Clinical Medicine and Surgery, Section of Dermatology, University Hospital Federico II of Naples, Naples, Italy.
² HMAP, Human Microbiome Advanced Project, Via Pelagio Palagi, 2, 20129, Milan, Italy.
³ HMAP, Human Microbiome Advanced Project, Via Pelagio Palagi, 2, 20129, Milan, Italy. FRinaldi@giulianipharma.com.

Abstract

Introduction: Several options are available to treat acne lesions, including topical benzoyl peroxide, topical retinoids, topical antibiotics, oral antibiotics, hormonal therapy, isotretinoin, and procedural therapies, such as light and laser therapies, although these cause side effects. This study aimed to establish the efficacy and tolerability of a class IIa medical device containing lactic acid, azelaic acid/polyglyceryl-3 copolymer, azelamidopropyl dimethyl amine, and bifida ferment lysate for the treatment of mild and moderate acne lesions.

Methods: A randomized, double-blind, placebo-controlled, multicentric study was carried out in which 60 persons of both genders aged ≥ 16 years affected by mild or moderate acne were enrolled. Each person used the product twice daily for 2 months. The clinical score (classified as absent, mild, moderate, and severe) of lesions such as blackheads, whiteheads, papules and pustules, erythema, desquamation, sebum secretion, and porphyrins production by a wood lamp was evaluated on the basis of a dermatologist's visual assessment at baseline (t₀) and after 2 months of treatment (t₁), and the results were compared between groups. Digital photographic images were also taken.

Results: Sixty subjects concluded the trial. It was observed that subjects treated with the medical device (group I) showed overall improvement in the analyzed acne lesions compared with placebo (group II) after 2 months of treatment. The efficacy of the treatment was also expressed as partial and total clearance. The medical device produced higher percentages of both partial and total clearance in all analyzed parameters, compared with the placebo group. The study was safe and well tolerated.

Conclusions: It was observed that the participants showed an overall improvement of the analyzed lesions in comparison with the placebo group, without adverse events during the trial. Hence, the medical device was found to be safe and effective in the treatment of mild or moderate acne.

Keywords: Azelaic acid/polyglyceryl-3 copolymer; Azelamidopropyl dimethyl amine; Bifida ferment lysate; Lactic acid; Mild acne; Moderate acne.