An interventional study of Active Cream and Placebo Cream without active substance in Skin, Skin Microbiome and Skin Microbiota, sponsored by AB Biotics, SA. Not yet recruiting. Open to female participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by AB Biotics, SA · Not applicable, Interventional, and Prevention
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.
This interventional, prospective clinical study aims to investigate the effects of topical application of two facial creams-one placebo and one containing active postbiotics (from Bifidobacterium and Pediococcus genera)-on the skin microbiome and appearance in women with sensitive skin and high sun exposure. The study is conducted remotely over a 14-week period and involves self-collection of skin microbiome samples and headshot photographs using the Haut AI application.
The primary objective is to identify changes in the skin microbiome and visual skin characteristics following the use of a placebo cream (Product A) for 6 weeks and an active cream (Product B) for 8 weeks. Secondary objectives include exploring the temporal dynamics of the microbiome, assessing self-perceived effects of the products, and documenting changes in skin appearance.
Participants are 30 women aged 40 to 60, residing in mid to west coast regions of the United States, representing all ethnicities and Fitzpatrick skin types. Eligible participants must have self-assessed sensitive skin (SS10 > 13), mild to moderate fine lines and wrinkles, and spend at least one hour outdoors under high sun exposure (10am-4pm) five times per week. They must be willing to replace their current skincare routine with the study regimen and maintain their lifestyle and diet throughout the study.
Exclusion criteria include prior use of the study products within the past three months, participation in similar studies within the last 30 days, active skin disorders, recent use of antibiotics, NSAIDs, corticosteroids, or hormone treatments, pregnancy or breastfeeding, and any medical conditions or procedures that could affect skin appearance. Participants must also demonstrate reliability and willingness to follow the study protocol.
The study design includes four microbiome sampling timepoints: after 2 weeks of placebo use (T0), at the end of the placebo phase (week 6, T1), after 4 weeks of active product use (week 10, T2), and at the end of the active phase (week 14, T3). At each timepoint, participants will collect a skin swab from the forehead and submit a headshot photo via the Haut AI app. A baseline photo is also collected before starting the regimen. They will also answer a questionnaire to assess the self-perceived evolution.
Each participant receives a study kit containing both products and four microbiome sampling kits. Participants will be instructed to apply 1 mL of product twice a day. Samples are returned to HelloBiome or directly to the lab for sequencing. Microbiome analysis is performed using 16S rRNA and ITS sequencing to detect bacterial and fungal communities. Data are processed and analyzed by HelloBiome using bioinformatics tools to assess microbial load, diversity, and composition.
Statistical analysis includes parametric and non-parametric tests (e.g., t-test, ANOVA, Mann-Whitney, Kruskal-Wallis, Wilcoxon signed-rank) and PERMANOVA for microbiome compositional data. Samples not meeting quality thresholds may be excluded from final analysis.
Data management ensures participant confidentiality through anonymization and secure storage on specific servers. Safety will be evaluated through the documentation of all adverse events.
AB Biotics, SA is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients will receive both products in a sequential manner. First 6 weeks of placebo base cream followed by 8 weeks of active cream.
Other: Active Cream · Other: Placebo Cream without active substance
Active facial cream with postbiotics from Bifidobacterium and Pediococcus genera. Product will be applied to the face twice a day in the morning and evening
Placebo facial cream without postbiotics with same other ingredients as active product. Product will be applied to the face twice a day in the morning and evening
Skin Microbiome
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.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Change in skin appearance
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.
Time frame: Baseline (week 2); Week 6, Week 10, Week 14
Self-perceived impact on skin characteristics.
Characterize self perceived positive or negative impacts of routine facial cream usage comparing between placebo and active in middle aged women with skin sensitivity along with high sun exposure. Patients will complete the SS10 questionnaire designed to capture self perceived changes as well as other custom questions.
Time frame: Baseline (week 2), Week 6, Week 10, Week 14
Eye bags / Eye area condition
Change in Eye bags / Eye area condition based on headshot photo taken by the Haut AI application. A total score will be recolected using a score of 0-100.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Hydration
Change in Hydration based on headshot photo taken by the Haut AI application. A total score will be recolected using a score of 0-100.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Lines
Change in Lines based on headshot photo taken by the Haut AI application. A total score will be recolected using a score of 0-100.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Pigmentation
Change in Pigmentation based on headshot photo taken by the Haut AI application. A total score will be recolected using a score of 0-100.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Pores
Change in Pores based on headshot photo taken by the Haut AI application. A total score will be recolected using a score of 0-100.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Redness
Change in Redness based on headshot photo taken by the Haut AI application. A total score will be recolected using a score of 0-100.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Translucency
Change in Translucency based on headshot photo taken by the Haut AI application. A total score will be recolected using a score of 0-100.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Uniformness
Change in Uniformness based on headshot photo taken by the Haut AI application. A total score will be recolected using a score of 0-100.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Acne
Change in Acne based on headshot photo taken by the Haut AI application. A total score will be recolected using a score of 0-100.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Skin Type
Change in Skin type based on headshot photo taken by the Haut AI application. It reflects how facial skin responds to internal and environmental factors, which may cause shifts between types like normal, oily, dry, and combination.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Skin tone
Change in Skin tone based on headshot photo taken by the Haut AI application. Skintone Classification algorithm analyses how tan the skin is and returns the result as one of the 6 values: Very light, Light, Intermediate, Tan, Brown, Dark.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Perceived Age
Change in Perceived Age based on headshot photo taken by the Haut AI application.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
ITA score
Change in ITA score based on headshot photo taken by the Haut AI application. Quantifies skin color using CIELAB color space.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
Eye Age
Change in Eye Age based on headshot photo taken by the Haut AI application. based on the part of the face that is most prone to the aging process: the areas around the eyes. Eye age reflects the pace of aging.
Time frame: Baseline (week 2), Week 6, Week 10 and Week 14
No study locations are listed for this record.
Plan to share: No — The study sponsor will evaluate requests on IPD
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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AB Biotics, SA