Evaluation of Oral Collagen Peptides on Skin Barrier Function in Women

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Skin; Dietary Supplement; Sensitive Skin; Dry Skin in the Elderly
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Investigational Product 1; Dietary supplement: Investigational Product 2

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Claire Cathelineau; Phone Number: 04 92 03 62 40; Email: cpcad@skinpharma.fr

Study Locations

• France
  • Nice, France, 06200
    • Recruiting
    • CPCAD - Centre Pharmacologie Clinique Appliqué à la Dermatologie, CHU Nice
    • Contact: Anne-Claire Cathelineau; Phone Number: 04 92 03 62 40; Email: cpcad@skinpharma.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; This product is going to be flavoured water
Active Comparator: Investigational product 1	Dietary supplement: Investigational Product 1; This product is going to be concentrated at 2000mg
Active Comparator: Investigational product 2	Dietary supplement: Investigational Product 2; This product is going to be concentrated at 5000mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Barrier Integrity, Hydration on the Face and Leg measured with Ph meter and Corneometer	The secondary objectives are to assess the effects of both concentrations on: - skin barrier integrity at two anatomical sites (on the face and leg) using the PH meter; _ Hydration using the corneometer	From the baseline until the end of the treatment at T3 Months

Collaborators and Investigators

• Sponsor: Centre de Pharmacologie Clinique Applique a la Dermatologie
• Collaborators: Rousselot BVBA

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: dietary supplement; dry skin; sensitive skin; cpcad; skinpharma
• Other Study ID Numbers: 2026-A00125-46 (Registry Identifier: 2026-A00125-46)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No