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

Background

Adult 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 aim

We 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 methods

In 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.

Results

One 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.

Conclusion

A 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.