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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Active Cream
  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
• Другое Placebo Cream without active substance
  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

Первичные конечные точки

• Skin Microbiome [Срок оценки: Baseline (week 2), Week 6, Week 10 and Week 14]
• Change in skin appearance [Срок оценки: Baseline (week 2); Week 6, Week 10, Week 14]

Вторичные конечные точки (12)

• Self-perceived impact on skin characteristics. [Срок оценки: Baseline (week 2), Week 6, Week 10, Week 14]
• Eye bags / Eye area condition [Срок оценки: Baseline (week 2), Week 6, Week 10 and Week 14]
• Hydration [Срок оценки: Baseline (week 2), Week 6, Week 10 and Week 14]
• Lines [Срок оценки: Baseline (week 2), Week 6, Week 10 and Week 14]
• Pigmentation [Срок оценки: Baseline (week 2), Week 6, Week 10 and Week 14]
• Pores [Срок оценки: Baseline (week 2), Week 6, Week 10 and Week 14]
• Redness [Срок оценки: Baseline (week 2), Week 6, Week 10 and Week 14]
• Translucency [Срок оценки: Baseline (week 2), Week 6, Week 10 and Week 14]
• Uniformness [Срок оценки: Baseline (week 2), Week 6, Week 10 and Week 14]
• Acne [Срок оценки: Baseline (week 2), Week 6, Week 10 and Week 14]
• Skin Type [Срок оценки: Baseline (week 2), Week 6, Week 10 and Week 14]
• Skin tone [Срок оценки: Baseline (week 2), Week 6, Week 10 and Week 14]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07454525 · 2025 KN102025 / Skinbiome

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗