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. 2025 Aug;15(8):2077-2097.
doi: 10.1007/s13555-025-01408-z. Epub 2025 Jun 11.

Scalp Microbiome Dynamics Can Contribute to the Clinical Effect of a Novel Antiseborrheic Dermatitis Shampoo Containing Patented Antifungal Actives: A Randomized Controlled Study

Martine Maître  1 , Sophie Baradat  2 , Mélanie Froliger  2 , Virginie Turlier  2 , Aimée Simcic-Mori  2 , Eléonore Gravier  2 , Camille Géniès  2 , Christophe Lauze  2 , Céline Huyghe  2 , Anaïs Noustens  2 , Sandrine Alvarez-Georges  2 , Rasvan Marinescu  2 , Pascal Reygagne  3 , Sandrine Bessou-Touya  2 , Valérie Mengeaud  4 , Hélène Duplan  2
Affiliations

Scalp Microbiome Dynamics Can Contribute to the Clinical Effect of a Novel Antiseborrheic Dermatitis Shampoo Containing Patented Antifungal Actives: A Randomized Controlled Study

Martine Maître et al. Dermatol Ther (Heidelb). 2025 Aug.

Abstract

Introduction: Scalp seborrheic dermatitis (SD) can cause physical discomfort and social embarrassment in affected individuals. Mild-to-moderate scalp SD can be managed using topical products with antifungal, antiinflammatory, and keratolytic properties.

Methods: A two-phase, randomized, controlled study was conducted to evaluate the clinical efficacy of a newly formulated anti-SD shampoo containing two patented antifungal actives and to investigate the associated changes in the scalp microbiota. The intervention involved a 2-week intensive phase for the 42 subjects included in the study, consisting of the application of the anti-SD shampoo three times a week; a randomized [1:1], controlled, parallel-group 8-week maintenance phase consisting of the test group applying the study shampoo once a week alternately with a neutral shampoo twice a week; and the control group applying the neutral shampoo alone three times a week.

Results: Following the intensive phase, the scalp condition improved substantially, as evidenced by a significant decrease in the severity of dandruff, erythema, and pruritus, associated with an improvement of SD dysbiosis. These improvements were more sustained in the test group than in the control group during the maintenance phase. The rediversification of the scalp microbiota involved a significant increase in fungal and bacterial richness along with a decrease in the level of SD-predominant Malassezia fungi and Staphylococcus bacteria and an increase in the level of low-abundant fungi genera belonging to the Ascomycota phylum.

Conclusions: The synergistic effects of antimycotic and antiinflammatory agents in the study shampoo likely contributed to rebalancing the fungal and bacterial ecosystem, thus improving scalp symptoms.

Gov identifier: NCT06578962 (retrospectively registered on 28 August 2024).

Keywords: Ascomycota; Anti-dandruff shampoo; Ciclopirox olamine; Dandruff; Fungal and bacterial populations; Microbiota diversity; Piroctone olamine; Scalp microbiota; Seborrheic dermatitis/scalp seborrheic dermatitis.

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Conflict of interest statement

Declarations. Conflict of Interest: Martine Maître, Sophie Baradat, Mélanie Froliger, Virginie Turlier, Aimée Simcic-Mori, Eléonore Gravier, Camille Géniès, Christophe Lauze, Céline Huyghe, Anais Noustens, Sandrine Alvarez-Georges, Rasvan Marinescu, Sandrine Bessou-Touya, Valérie Mengeaud, and Hélène Duplan are or were employees of Pierre Fabre Dermo-Cosmétique and Personal Care, France, at the time of the preparation of this manuscript and received salaries, but they do not have any financial interest in the findings described in this manuscript. Pascal Reygagne has previously received honorarium fees Pierre Fabre Dermo-Cosmétique and Personal Care for his role as a speaker, advisory board member, and investigator but did not receive any financial compensation for the performance in this study. Ethical Approval: The study was performed in compliance with the Declaration of Helsinki and its subsequent amendments, as well as good clinical practice guidelines (CHMP/ICH/135/1995 and integrated addendum). It also conformed to Regulation (EC) No. 1223/2009 of the European Commission and the French Decree (no. 2017-884) pertaining to research on cosmetic products. As registration of studies evaluating cosmetic products is not mandatory in the European Union, the study was retrospectively registered under trial number NCT06578962 (28 August 2024) for publication. Prior to enrollment, all subjects provided written informed consent.

Figures

Fig. 1
Fig. 1
Study design (A) and flow chart (B). Description of the intensive phase and maintenance phase of the intervention scheme, and parameters evaluated in the subjects during the 4 study visits: week 0 (W0, baseline), W2 (end of intensive phase/randomization), W6, and W10 (end of maintenance phase). IGA investigator global assessment, PGA patient global assessment
Fig. 2
Fig. 2
Clinical symptoms evaluated and global clinical efficacy. Changes in dandruff (A), erythema (B), and pruritus (C) severity mean scores during the intensive (N = 42) and the maintenance (N = 21 in each group) phases. During the maintenance phase, intergroup analyses are shown in black, and intragroup analyses are shown in green (control group) and blue (test group) at the selected timepoint versus week 2 (W2). *p < 0.05; **p < 0.001; ***p < 0.0001. D Investigator global assessment (IGA) and E patient global assessment (PGA) at W2 in the whole study population (N = 42) and at W6 and W10 in the control and test groups (N = 21 in each group). The percentages of subjects who had improvement (comprising complete resolution, significant improvement, and slight improvement), stabilization, or worsening of scalp condition are shown next to the bars at W6 and W10. The Wilcoxon rank-sum test was used to compare groups. **p < 0.001; ***p < 0.0001
Fig. 3
Fig. 3
Scalp fungal analysis. Intensive phase: Subfigures A–D. Maintenance Phase: Subfigures E–F. A Mean relative abundances (%) of the top ten fungal genera at baseline week 0 (W0) and after the intensive phase (W2) in a subset of subjects (N = 31). B Absolute quantification of Malassezia globosa and Malassezia restricta at W0 and W2 (mean ± SD Log10 values), as determined by droplet digital PCR™ (N = 42). Differences between time points: **p < 0.001. C Boxplots for the four alpha-diversity indices analyzed during the intensive phase (median [min–max], N = 31). Differences between time points: **p < 0.001; ***p < 0.0001 D Phylogenetic trees of the scalp fungal population at baseline (W0) and after the intensive phase (W2). Colors and thickness of the branches are proportional to the abundance of each phylum, class, family, or genus. E Changes in the mean relative abundances of the top ten fungal genera during the maintenance phase (W2 to W10) in the control (N = 16) and test (N = 15) groups. F Boxplots for the four alpha-diversity indices analyzed during the maintenance phase (median [min–max]). Differences between time points: ***p ≤ 0.0001
Fig. 3
Fig. 3
Scalp fungal analysis. Intensive phase: Subfigures A–D. Maintenance Phase: Subfigures E–F. A Mean relative abundances (%) of the top ten fungal genera at baseline week 0 (W0) and after the intensive phase (W2) in a subset of subjects (N = 31). B Absolute quantification of Malassezia globosa and Malassezia restricta at W0 and W2 (mean ± SD Log10 values), as determined by droplet digital PCR™ (N = 42). Differences between time points: **p < 0.001. C Boxplots for the four alpha-diversity indices analyzed during the intensive phase (median [min–max], N = 31). Differences between time points: **p < 0.001; ***p < 0.0001 D Phylogenetic trees of the scalp fungal population at baseline (W0) and after the intensive phase (W2). Colors and thickness of the branches are proportional to the abundance of each phylum, class, family, or genus. E Changes in the mean relative abundances of the top ten fungal genera during the maintenance phase (W2 to W10) in the control (N = 16) and test (N = 15) groups. F Boxplots for the four alpha-diversity indices analyzed during the maintenance phase (median [min–max]). Differences between time points: ***p ≤ 0.0001
Fig. 4
Fig. 4
Scalp bacterial analysis. Intensive phase: Subfigures A–D. Maintenance Phase: Subfigures E–F. A Mean relative abundances (%) of the top ten bacterial genera at baseline week 0 (W0) and after the intensive phase (W2) in a subset of subjects (N = 31). B Absolute quantification of Cutibacterium acnes and Staphylococcus epidermidis at W0 and W2 (mean ± SD Log10 values), as determined by droplet digital PCR™ (N = 42). Differences between time points: **p < 0.001. C Boxplots for the four alpha-diversity indices analyzed during the intensive phase (median [min–max], N = 31). Differences between time points: *p < 0.05. D Phylogenetic trees of the scalp bacterial population at baseline (W0) and after the intensive phase (W2). Colors and thickness of the branches are proportional to the abundance of each phylum, class, family, or genus. E Changes in the mean relative abundances of the top ten bacterial genera during the maintenance phase (W2 to W10) in the control (N = 16) and test (N = 15) groups. F Boxplots for the four alpha-diversity indices analyzed during the maintenance phase (median [min–max]). Differences between time points: *p < 0.05
Fig. 4
Fig. 4
Scalp bacterial analysis. Intensive phase: Subfigures A–D. Maintenance Phase: Subfigures E–F. A Mean relative abundances (%) of the top ten bacterial genera at baseline week 0 (W0) and after the intensive phase (W2) in a subset of subjects (N = 31). B Absolute quantification of Cutibacterium acnes and Staphylococcus epidermidis at W0 and W2 (mean ± SD Log10 values), as determined by droplet digital PCR™ (N = 42). Differences between time points: **p < 0.001. C Boxplots for the four alpha-diversity indices analyzed during the intensive phase (median [min–max], N = 31). Differences between time points: *p < 0.05. D Phylogenetic trees of the scalp bacterial population at baseline (W0) and after the intensive phase (W2). Colors and thickness of the branches are proportional to the abundance of each phylum, class, family, or genus. E Changes in the mean relative abundances of the top ten bacterial genera during the maintenance phase (W2 to W10) in the control (N = 16) and test (N = 15) groups. F Boxplots for the four alpha-diversity indices analyzed during the maintenance phase (median [min–max]). Differences between time points: *p < 0.05
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