Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females (NCT06057883) | Clinical Trial Compass
CompletedPhase 2
Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females
France35 participantsStarted 2023-09-27
Plain-language summary
The goal of this clinical trial is to test to efficacy of a probiotic blend on stress and skin appearance in young females. It is hypothesized that those taking the probiotic blend will have decreased levels of perceived stress and this will be reflected positively on their skin appearance.
Who can participate
Age range30 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Females between 30 to 45 years old, inclusive.
✓. Caucasian type.
✓. Normal to dry skin to the face (excluded very dry skin).
✓. Have a regular menstrual cycle (participants not known to have hormonal imbalance, be in the pre-menopausal or menopausal state).
✓. Have a skin phototype I, II or III.
✓. Have a negative urine pregnancy test at screening and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months, and participants must agree to sign a release form (Appendix 4).
✓. Able to give free, informed and express consent to participate,
✓. Affiliated with social security in accordance with the recommendations of the French law (Loi Jardé: n° 2016-1537 - 16.11.16) concerning biomedical research.
Exclusion criteria
✕. Currently pregnant, or breast feeding, or planning to be pregnant during the study.
✕. Current smoker.
✕. Suffering from a chronic or acute skin condition on the face and forearms (atopic dermatitis, acne, eczema, psoriasis, rash, severe dryness, etc.), unless the condition is deemed stabilized and will not affect study outcomes or be negatively affected by the intervention in the opinion of the investigator.
What they're measuring
1
The effect of the probiotic intake on perceived stress levels.
✕. Current use of antiaging products, unless the participant has been using the same product, with the same frequency and concentration for the past ≥ 3 months.
✕. Introduction of a new antiaging product during the study, or a change in the frequency or concentration of a routinely used antiaging product.
✕. Introduction of new skin care products during the study, unless medically prescribed.
✕. Facial surgery 5 years before study start.
✕. Chemical treatment (e.g., Botox injection) within 1 year before study start.