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

NCT07454525 | Not Yet Recruiting

• 1 other identifier: 2025 KN102025 / Skinbiome
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Skin Ageing; Skin; Skin Microbiome; Skin Microbiota

Keywords

Microbiome; Skin; Skin ageing; Fine lines; Face Skin; Sun exposure; Skin appearance

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline (week 2); Week 6, Week 10, Week 14

Secondary Outcomes (15)

• Self-perceived impact on skin characteristics.

  Baseline (week 2), Week 6, Week 10, Week 14

• Eye bags / Eye area condition

  Baseline (week 2), Week 6, Week 10 and Week 14

• Hydration

  Baseline (week 2), Week 6, Week 10 and Week 14

• Lines

  Baseline (week 2), Week 6, Week 10 and Week 14

• Pigmentation

  Baseline (week 2), Week 6, Week 10 and Week 14

Study Arms (1)

Study Arm

OTHER

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

Interventions

Active Cream OTHER

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

Study Arm

Placebo Cream without active substance OTHER

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

Study Arm

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 40-60 among all ethnicities and Fitzpatrick scale.
• With self-assessed sensitive skin (SS10 \> 13) and self-reported mild to moderate fine lines and wrinkles.
• Must spend minimum 1 hour outside from 10am-4pm at least 5 times per week.
• Residing within the same country on the mid to west coast (California, Nevada, Utah, Arizona, Colorado, New Mexico, Kansas, Oklahoma, Texas, Illinois, Kansas, Idaho, Nebraska, Montana).
• Consider themselves to be in good health.
• Willing to continue to use their current cosmetic products (foundation, blush, eyeshadow, sunscreen, etc.) and with the same routine/frequency if they do not contain anti-aging ingredients.
• Willing to refrain from using AHA, other peeling acids (PHA, BHA), prescription products such as retinoids or hydroquinone etc. during the study.
• Willing to take skin swabs to support measures of the skin microbiome.
• Must understand their role in the study, provide written informed consent, and fully participate over the 14-week period.
• Willing to use the products provided within the study as instructed. Willing to change their current skincare routine and replace it with the given regimen for 14 weeks.
• Willing to maintain diet and lifestyle (including physical exercise) during study period.

You may not qualify if:

• Used any of the products to be tested in the claim study in the past 3 months. - Participation in a similar skin study within the past 30 days.
• Have active skin disorders such as psoriasis, eczema, allergies, wounds, scars, or severe acne on their forehead.
• Regular use of probiotic supplements
• Consumption of fermented foods (including kefir, probiotic containing yoghurt, kombucha or other) for more than 5 times a week
• Are orally or topically using or have used in the past 6 months: antibiotics, NSAIDS, antihistamines, immuno-suppressants, corticosteroids, prescription products such as retinoids, hydroquinone, or strong AHA treatments.
• Have started hormonal treatment (e.g., contraceptives, fertility treatments, or HRT for menopause) within the past 3 months or in case they are on a treatment for more than 3 months they are unwilling to maintain a stable regimen for the duration of the study.
• Pregnant or breastfeeding.
• Any history of significant disease or medical condition to alter skin appearances such as type 2 diabetes, cancer, renal disorders or hepatic dysfunction.
• Individuals who have had medical procedures in their face such as laser resurfacing (or any type of laser treatment ex. photo depilation), plastic surgery (including Botox) within the last 12 months or history of UV radiation (tanning and facial lamps) within the last 3 months.
• Active Vitiligo or any other chronic skin conditions.
• Individuals with any history that, in the investigator's opinion, indicates potential harm to the subject or could jeopardize the validity of the study.
• History of poor cooperation, non-compliance, unreliability, or unwillingness to follow the research protocol and timeline.

Sponsors & Collaborators

• AB Biotics, SA: lead
• Hellobiome: collaborator
• Kaneka Americas Holding Inc.: collaborator

Central Study Contacts

Maria Rodriguez-Palmero, PhD

CONTACT

+34 638679157; rodriguezpalmero@ab-biotics.com

Nuria Gispets, MSc

CONTACT

+34 607026612; gispets@ab-biotics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Products will be labeled as Product A and Product B. Participants will be blinded to study product composition
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: March 6, 2026
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share