Overview
This clinical study aims to determine whether taking two different doses of collagen-derived peptides for three months improves facial skin barrier integrity in women with dry, sensitive skin, compared with a placebo.
Description
This study is designed to evaluate whether daily supplementation with collagen-derived peptides can improve the skin barrier of the face in women who have dry and sensitive skin. Participants will receive one of two different concentrations of collagen-derived peptides or a placebo, and the effects will be assessed after three months of treatment. The main goal is to compare the two active supplement doses against placebo to see if collagen peptides help strengthen or restore skin barrier integrity.
The secondary objectives are to assess the impact of both concentrations on:
- skin barrier integrity at two anatomical sites (face and leg) at T1, T2 and T3 (Tewameter®);
- skin hydration at two anatomical sites (face and leg) at T1, T2 and T3 (Corneometer®);
- skin barrier resistance (leg) after 10 strippings at T2 and T3 (Tewameter®);
- skin barrier permeability (leg) at T2 and T3 (Caffeine penetration assay);
- skin elasticity at two anatomical sites (face and leg) at T1, T2 and T3 (Cutometer®);
- skin pH (face) at T1, T2 and T3 (pH-Meter®);
- crow's feet wrinkles and fine lines at T1, T2 and T3 (PRIMOS®);
- dermal thickness (Face) at T1, T2 and T3 (Dermscan®);
- clinical signs (dryness, roughness, redness) at T1, T2 and T3 (clinical assessments);
- subjective symptoms (tightness, itching, burning sensation) at T1, T2 and T3 (subject evaluation);
- ceramide levels and other skin lipids (leg) at T2 and T3 (D-squame®);
- ceramide levels and other skin lipids (face) at T3 (D-squame®);
- participant perceived efficacy (Self-assessment questionnaire) at T1, T2 and T3;
- safety at an ongoing basis (Adverse Event reporting).
Eligibility
Inclusion Criteria:
- Participant having signed an Informed Consent Form (ICF);
- Healthy female Participant aged 45 to 70 years inclusive not followed by a healthcare practitioner for any skin disease;
- Participant with phototype II to IV according to the Fitzpatrick classification;
- Participant with dry skin measured on the cheeks (Tewameter, TEWL \>15g/m²/h (skin barrier integrity) on back of the cheekbone)
- Female Participant of non-childbearing potential, defined as a woman without uterus and/or both ovaries, surgically sterile (at least 6 months prior to Screening visit) or post-menopausal (at least one year post cessation of menses);
- Female Participant of childbearing potential who has been using a highly effective birth control method for at least 1 month prior to Screening visit and agreeing to continue adequate contraception during the entire study period;
Highly effective birth control methods are:
\- hormonal (combined or progestogen-only) contraception methods associated with inhibition of ovulation or intrauterine device; bilateral tubal occlusion since at least 3 months prior to Screening visit; vasectomised partner; True abstinence, i.e., refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant.
- Participant agreeing not to apply any cosmetic product (e.g. care cream, lotion, body milk) or drug on the face (except usual cleansing products) within 24 hours before the study visits;
- Participant agreeing to not apply cosmetic, medical, or aesthetic treatments out of the study protocol on the face and legs during the whole study duration;
- Participant affiliated to a health social security system (according to French Law).
Exclusion Criteria:
- Participant with a BMI ≤17 or ≥30 kg/cm²;
- Participant with any uncontrolled diseases such as diabetes, hypertension, hyperthyroidism or hypothyroidism;
- Presenting or having a history of eating disorder (e.g. anorexia, food allergy) or gastrointestinal malabsorption such as celiac disease, Crohn's disease, lactose intolerance;
- Participant with an history of sleeve or bypass;
- Participant currently participating in another clinical study or being in an exclusion period of another clinical study;
- Participant with known or suspected hypersensitivity to any component(s) of the investigational products or to any ingredients of the vehicles (i.e., excipients);
- Participant with a known allergy to beef-derived products;
- Participant who has used collagen supplements, vitamin C, or other skin related nutraceuticals within the last 3 months
- Participant who started using prescription medications to treat skin conditions or other medications that affect the skin during the three months prior to the study
- Participant who has made significant lifestyle changes in the past three months (altering their diet, starting new exercises, or changing their skincare routines)
- Participant with skin abnormalities (e.g., scars, excessive hair, tattooing) or any dermatosis (e.g., psoriasis, eczema, acne vulgaris) on the face and legs which could interfere with the study;
- Participant impossible to contact in case of emergency;
- Participant who, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state);
- Participant who is in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomization;
- Protected participant as defined in the Articles of the French Public Health Code. Article 1121-7: person deprived of liberty by a judicial or administrative decision, or participant to psychiatric care, or person admitted to a health or social institution for purposes other than the research. Article 1121-8: adult person participant to a legal protection measure or unable to express his/her consent. Article L3212-1: person undergoing compulsory psychiatric treatment. Article L3213-1: person having a mental disorder that requires care and that which may compromise the safety of third persons or seriously undermine public order;
- Participant unable to communicate or cooperate with the Investigator;
- Participant having received 6000 euros indemnities for participation in clinical trials/investigations in the 12 previous months, including participation in the present study (according to French Law);
