Examine Impact of Topical Application of Active Versus Placebo on the Skin Microbiome in Sensitive Skin. (SkinBiome)

NCT07454525 NA NOT_YET_RECRUITING

The purpose of this study is to build insights to understand how the placebo and active impacts the skin microbiome in women with high skin sensitivity (SS10 \> 13) and sun exposure. Microbiome samples will be taken at baseline after 2 weeks of using the placebo (base without active) as a run-in period followed by the usage of placebo for an additional 4 weeks. The participants will then start the usage of active formula for an additional 8 weeks with microbiome samples collected at the 10-week and 14-week. This will allow us to observe how the microbiome changes over time after the product usage of both placebo and active formulations relative to the pre-regimen condition. In addition, headshot photos will be taken using the Haut AI application at each time point concurrent to the microbiome sample collection to examine changes in skin appearances after the regimen.

Details

Lead sponsor	AB Biotics, SA
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	45
Start date	2026-02
Completion	2026-06

Conditions

• Skin
• Skin Microbiome
• Skin Microbiota
• Skin Ageing

Interventions

• Active Cream
• Placebo Cream without active substance

Primary outcomes

• Skin Microbiome — Baseline (week 2), Week 6, Week 10 and Week 14
  Changes in the skin microbiome composition. Composition will be evaluated by using next-generation sequencing (NGS) through a total of 14-weeks usage of placebo (Product A - base formulation) for 6 weeks and active (Product B - Base formulation + active postbiotics) for 8 weeks in middle aged older women with sensitive skin with high sun exposure.
• Change in skin appearance — Baseline (week 2); Week 6, Week 10, Week 14
  Change in skin appearance based on headshot photo taken by the Haut AI application. Evolution of skin parameters will be evaluated; A total score will be calculated by summing total scores of: Eye bags, Hydration, Lines, Pigmentation, Pores, Redness, Translucency and Uniformness. All of them get a score of 0-100, therefore we will get a total score of 0-800.