Examine Impact of Topical Application of Active Versus Placebo on the Skin Microbiome in Sensitive Skin.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorAB Biotics, SA
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Active Cream
Other interventionActive 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 Cream without active substance
Other interventionPlacebo 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
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Study ArmOther 2 interventions
Trial outcomes
Primary outcomes
1
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 142
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 14Secondary outcomes
1
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 142
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 143
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 144
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 14Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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