Dry SkinNCT07529249
Evaluation of Oral Collagen Peptides on Skin Barrier Function in Women
A study testing Investigational Product 1 and Investigational Product 2 in people with Dry Skin and Sensitive Skin, run by Centre de Pharmacologie Clinique Applique a la Dermatologie at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dry Skin, Sensitive Skin, Dry Skin in the Elderly
- What is being tested?
- Investigational Product 1 and Investigational Product 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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);
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- 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);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CPCAD - Centre Pharmacologie Clinique Appliqué à la Dermatologie, CHU Nice
Nice, 06200
Anne-Claire Cathelineau, 04 92 03 62 40, cpcad@skinpharma.fr
About this study
Official title: 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.
Read the 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).
- Conditions
- Dry Skin, Sensitive Skin, Dry Skin in the Elderly, Dietary Supplement
- Being tested
- Investigational Product 1, Investigational Product 2, Placebo
- Keywords
- cpcad, skinpharma, dry skin, dietary supplement, sensitive skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Product 1Dietary supplement
This product is going to be concentrated at 2000mg
Investigational Product 2Dietary supplement
This product is going to be concentrated at 5000mg
PlaceboDietary supplement
This product is going to be flavoured water
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Investigational product 1 | Active comparator | Not described Receives: Dietary Supplement: Investigational Product 1 |
| Investigational product 2 | Active comparator | Not described Receives: Dietary Supplement: Investigational Product 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: From the baseline until the end of the treatment at T3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Pharmacologie Clinique Applique a la Dermatologie
- Sponsor type
- University, hospital or other
- Collaborators
- Rousselot BVBA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529249
- Sponsor's protocol ID
- 2026-A00125-46
- Other IDs
- 2026-A00125-46
- Status last verified
- May 2026
- First submitted
- 26 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Collagen Peptides on Skin Barrier Function in Women With Dry Skin
- ClinicalTrials.gov ID
- NCT07529249
- Acronym / sponsor ID
- 2026-A00125-46
- Conditions
- Dry Skin, Sensitive Skin, Dry Skin in the Elderly, Dietary Supplement
- Keywords
- cpcad, skinpharma, dry skin, dietary supplement, sensitive skin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre de Pharmacologie Clinique Applique a la DermatologieUniversity, hospital or other
- Collaborators
- Rousselot BVBA
- Study start
- Apr 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Investigational product 1 | Active comparator | Dietary Supplement: Investigational Product 1 |
| Investigational product 2 | Active comparator | Dietary Supplement: Investigational Product 2 |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Product 1This product is going to be concentrated at 2000mg | Dietary supplement | Investigational product 1 |
| Investigational Product 2This product is going to be concentrated at 5000mg | Dietary supplement | Investigational product 2 |
| PlaceboThis product is going to be flavoured water | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Product 1 and Investigational Product 2 in people with Dry Skin and Sensitive Skin, run by Centre de Pharmacologie Clinique Applique a la Dermatologie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Claire Cathelineau (04 92 03 62 40, cpcad@skinpharma.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.