Efficacy of a retinoid complex plus anti‐inflammatory component cream alone or in combination with prebiotic food supplement in adult acne: A randomized, assessor‐blinded, parallel‐group, multicenter trial on 184 women
Authors: Kazandjieva Jana , Dimitrova Jenya , Sankeva Marina , Yankov Daniel , Bocheva Valeria , Kircheva Kamelia , Gincheva Veronika , Gospodinova Klimentina , Andasorova Reni , Milanova Maya , Jeleva Denitsa , Zlateva Petya , Vasileva Irida , Yankova Rumyana , Gotseva Svetlana , Dakova Tsvetelina , Zografova Emiliya , Marina Sonya , Kateva Marieta , Broshtilova Valentina , Todeva Violina , Tsankov Nikolay , Mitova Zlatka , Boyanova Natalia , Milani Massimo 
Published: May 2022

AbstractBackgroundAdult female acne (AFA) nowadays is a very common skin condition affecting mainly women aged between 25 and 40. The treatment of AFA could be challenging.Study aimWe evaluate and compare the efficacy and tolerability of a cream formulation containing two retinoid molecules (hydroxypinacolone/retinyl palmitate) combined with Iris Florentina root extract and a complex of three oligopeptides (C) applied twice a day (morning and evening) alone or in combination (C + O) with a food supplement containing a mixture of prebiotic molecules (FOS&GOS) zinc, lactoferrin, and niacinamide.Subjects and methodsIn a multicenter, randomized, assessor‐blinded, 12‐week trial, we assessed the efficacy of these two regimens in the evolution of AFA lesions (non‐inflammatory: NI‐L; inflammatory: IL; and total number of lesions: TL). Additional efficacy endpoints were the evolution of the 6‐point (from 0 to 5) GEA and Adult Female Acne Scoring Tool (AFAST) scores.ResultsOne hundred and eighty‐four women (mean age 32 ± 6 years) with AFA agreed to participate after obtaining informed consent. They were randomized (2:1) to the topical product (n = 123) (Group C) or to the combination (n = 61) (Group C + O) treatment. All enrolled patients concluded the trial with no drop‐out. At baseline, NI‐L, IL, and TL acne lesion count were 15 ± 9, 9 ± 5, and 24 ± 14 in the Group C and 19 ± 8, 9 ± 4, and 29 ± 10 in Group C + O. In comparison with the number of the acne lesions at the baseline, both treatment regimens induced a significant reduction (p = 0.0001, ANOVA test) at Week 12 in NI‐L, IL, and TL by −54%, −63%, and − 59% in Group C and by −55%, −73%, and − 61% in the Group C + O, respectively. At Week 12, the absolute IL count reduction vs. baseline was significantly (p = 0.0158) greater in Group C + O (−7.0) in comparison with Group C (−5.5). The GEA absolute score reduction in Group C + O group was significantly greater in comparison with Group C (−1.5 vs. −1.1;p = 0.0097). In the Group C + O, a greater percentage of success treatment (defined as a GEA score of 0/1 at Week 12) was observed in comparison with Group C (39% vs. 27%;p = 0.06). AFAST score at baseline was 2.4 ± 0.5 in group C and 2.8 ± 0.6 in group C + O. AFAST score was reduced by 21% and by 51% after 6 and 12 weeks of treatment in group C and by 22% and 55% in group C + O, respectively. Both treatment regimens were well tolerated. Not relevant adverse events were recorded.ConclusionA cream containing retinoid molecules and Iris Florentina root extract is effective and well tolerated in the management of AFA. The treatment combination with a prebiotic and anti‐inflammatory food supplement offers an additional clinical benefit mainly in reducing inflammatory lesions and improving the severity acne score.