Evaluation of Oral Collagen Peptides on Skin Barrier Function in Women

May 7, 2026 updated by: Centre de Pharmacologie Clinique Applique a la Dermatologie

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nice, France, 06200
        • Recruiting
        • CPCAD - Centre Pharmacologie Clinique Appliqué à la Dermatologie, CHU Nice
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Facial Skin Barrier Integrity Measured by Tewameter After 3 Months of Supplementation
Time Frame: from baseline until the end of treatment at T3 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Skin Barrier Integrity, Hydration on the Face and Leg measured with Ph meter and Corneometer
Time Frame: From the baseline until the end of the treatment at T3 Months

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre de Pharmacologie Clinique Applique a la Dermatologie

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rousselot BVBA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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