Oral collagen peptides to improve facial skin barrier in women

Evaluation of Oral Collagen Peptides on Skin Barrier Function in Women With Dry Skin

See if taking two different doses of oral collagen peptides for three months helps improve facial skin barrier in women with dry, sensitive skin.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 45 Years to 70 Years
• Sex: Female
• Sponsor: Centre de Pharmacologie Clinique Applique a la Dermatologie (Academic / other)
• Locations: 1 site (Nice)
• Trial ID: NCT07529249 on ClinicalTrials.gov

What this trial studies

This interventional trial gives women with dry, sensitive facial skin one of two daily doses of collagen-derived peptides or a placebo for three months and compares changes in skin barrier integrity. The primary measure is transepidermal water loss on the cheek, with additional measurements of hydration, elasticity, pH, wrinkle appearance, dermal thickness, lipid content, and barrier recovery at face and leg using standardized devices and assays at multiple visits. Participants are healthy women aged 45–70 with Fitzpatrick phototypes II–IV and a defined TEWL threshold at screening. The trial is conducted at CPCAD/CHU Nice and sponsored in collaboration with a collagen supplier.

Who should consider this trial

Good fit: Women aged 45–70 with dry, sensitive facial skin (TEWL >15 g/m²/h on the cheek), Fitzpatrick phototypes II–IV, and who are postmenopausal, surgically sterile, or using highly effective contraception are eligible.

Not a fit: People with active treated skin disease, outside the specified age or phototype ranges, pregnant, or who do not meet the TEWL threshold are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, oral collagen peptides could strengthen the facial skin barrier and reduce symptoms of dryness and sensitivity.

How similar studies have performed: Previous small trials of oral collagen peptides have reported modest improvements in skin hydration and elasticity, but evidence specifically for improving facial barrier function is limited.

Eligibility criteria

Inclusion Criteria:

1. Participant having signed an Informed Consent Form (ICF);
2. Healthy female Participant aged 45 to 70 years inclusive not followed by a healthcare practitioner for any skin disease;
3. Participant with phototype II to IV according to the Fitzpatrick classification;
4. Participant with dry skin measured on the cheeks (Tewameter, TEWL \>15g/m²/h (skin barrier integrity) on back of the cheekbone)
5. 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);
6. 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.
7. 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;
8. 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;
9. Participant affiliated to a health social security system (according to French Law).

Exclusion Criteria:

1. Participant with a BMI ≤17 or ≥30 kg/cm²;
2. Participant with any uncontrolled diseases such as diabetes, hypertension, hyperthyroidism or hypothyroidism;
3. 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;
4. Participant with an history of sleeve or bypass;
5. Participant currently participating in another clinical study or being in an exclusion period of another clinical study;
6. Participant with known or suspected hypersensitivity to any component(s) of the investigational products or to any ingredients of the vehicles (i.e., excipients);
7. Participant with a known allergy to beef-derived products;
8. Participant who has used collagen supplements, vitamin C, or other skin related nutraceuticals within the last 3 months
9. 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
10. Participant who has made significant lifestyle changes in the past three months (altering their diet, starting new exercises, or changing their skincare routines)
11. 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;
12. Participant impossible to contact in case of emergency;
13. 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);
14. Participant who is in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomization;
15. 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;
16. Participant unable to communicate or cooperate with the Investigator;
17. 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);

Where this trial is running

Nice

• CPCAD - Centre Pharmacologie Clinique Appliqué à la Dermatologie, CHU Nice — Nice, France (Recruiting)

Study contacts

• Study coordinator: Anne-Claire Cathelineau

Conditions Dry Skin; Sensitive Skin; Dry Skin in the Elderly; Dietary Supplement; cpcad; skinpharma; dry skin; dietary supplement