Evaluation of Oral Collagen Peptides on Skin Barrier Function in Women

NCT07529249 | Not Yet Recruiting Phase 1

• 1 other identifier: 2026-A00125-46
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Skin; Sensitive Skin; Dry Skin in the Elderly; Dietary Supplement

Keywords

cpcad; skinpharma; dry skin; dietary supplement; sensitive skin

Outcome Measures

Primary Outcomes (1)

• Change in Facial Skin Barrier Integrity Measured by Tewameter After 3 Months of Supplementation

  The primary objective of this study is to assess the effects of 2 concentrations of collagen-derived peptides, compared to a placebo, on facial skin barrier integrity using a Tewameter, after three months of daily supplementation in women with dry and sensitive skin.

  from baseline until the end of treatment at T3 months

Secondary Outcomes (1)

• Skin Barrier Integrity, Hydration on the Face and Leg measured with Ph meter and Corneometer

  From the baseline until the end of the treatment at T3 Months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Investigational product 1

ACTIVE COMPARATOR

Drug: Investigational Product 1

Investigational product 2

ACTIVE COMPARATOR

Drug: Investigational Product 2

Interventions

Investigational Product 1 DRUG

This product is going to be concentrated at 2000mg

Investigational product 1

Placebo DIETARY_SUPPLEMENT

This product is going to be flavoured water

Placebo

Investigational Product 2 DRUG

This product is going to be concentrated at 5000mg

Investigational product 2

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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);
• 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);

Sponsors & Collaborators

• Centre de Pharmacologie Clinique Applique a la Dermatologie: lead

Study Sites (1)

CPCAD - Centre Pharmacologie Clinique Appliqué à la Dermatologie, CHU Nice

Nice, 06200, France

Location

Central Study Contacts

Anne-Claire Cathelineau

CONTACT

04 92 03 62 40; cpcad@skinpharma.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (1)