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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-A00125-46 | Registry Identifier | 2026-A00125-46 |
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| Name | Class |
|---|---|
| Rousselot BVBA | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
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| Investigational product 1 | Active Comparator |
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| Investigational product 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Product 1 | Dietary Supplement | This product is going to be concentrated at 2000mg |
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| 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 |
| 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 |
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Inclusion Criteria:
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).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne-Claire Cathelineau | Contact | 04 92 03 62 40 | cpcad@skinpharma.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPCAD - Centre Pharmacologie Clinique Appliqué à la Dermatologie, CHU Nice | Recruiting | Nice | 06200 | France |
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| Investigational Product 2 | Dietary Supplement | This product is going to be concentrated at 5000mg |
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| Placebo | Dietary Supplement | This product is going to be flavoured water |
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