Efficacy of a Combined Oral and Topical Collagen Regimen Compared to Topical Collagen or Oral Collagen Regimens in Women With Skin Ageing Signs

NCT07473037 | Not Yet Recruiting

• 1 other identifier: VCY25-007
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical study is conducted at one study site and in 165 women with visible signs of skin aging. It compares after 13 weeks the benefit of a combined oral collagen supplement and topical collagen serum regimen compared with oral collagen alone and topical collagen serum alone in reducing in women presenting visible signs of skin ageing .

Conditions

Visible Skin Aging Signs; Wrinkles and Folds in Lower Face; Skin Ageing; Skin Elasticity; Skin Firmness; Skin Evenness; Skin Radiance; Skin Smoothness; Skin Density

Outcome Measures

Primary Outcomes (1)

• Crow's feet score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 6=very deep severe wrinkles

  Baseline, Week 3, Week 7, Week 13

Secondary Outcomes (22)

• Forhead wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles

  baseline, week 3, week 7, week 13

• Glabellar's wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles

  baseline, week 3, week 7, week 13

• Underneath eye wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 5=very deep/severe wrinkles

  baseline, week 3, week 7, week 13

• Nasolabial fold score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no fold to 5=very deep/severe fold

  baseline, week 3, week 7, week 13

• Upper lip wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=no wrinkles to 6=very deep/severe wrinkles

  baseline, week 3, week 7, week 13

Other Outcomes (1)

• Microbiopsies (0.33 mm in diameter or the equivalent of a 23-gauge needle) for histology and gene expression of tissue rejuvenation at baseline and week 13

  baseline, week 13

Study Arms (3)

Group 1: Combined oral collagen supplement + topical collagen serum

EXPERIMENTAL

combination of oral collagen supplementation and topical application of collagen serum

Dietary Supplement: Oral collagen; Other: topical application of collagen serum

Group 2: Oral collagen supplement alone

ACTIVE COMPARATOR

oral collagen supplementation

Dietary Supplement: Oral collagen

Group 3: Topical collagen serum alone

ACTIVE COMPARATOR

topical application of collagen serum

Other: topical application of collagen serum

Interventions

Oral collagen DIETARY_SUPPLEMENT

combination of oral collagen supplementation and topical application of collagen serum

Group 1: Combined oral collagen supplement + topical collagen serum; Group 2: Oral collagen supplement alone

topical application of collagen serum OTHER

topical application of collagen serum

Group 1: Combined oral collagen supplement + topical collagen serum; Group 3: Topical collagen serum alone

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant having signed an Informed Consent Form (ICF) before any trial related activity is carried out;
• Female participant;
• Participant with a Fitzpatrick skin type I to III;
• Participant aged 45 to 60 years inclusive at the time of signing the ICF;
• Participant with a BMI ≥20 and \< 29 kg/m²;
• Participant presenting:
• Cheek firmness score ≥3 and ≤6 on the 10-point scale;
• Crow's feet wrinkle score ≥2 and ≤4 on the L'Oréal Atlas;
• Global facial wrinkle score ≥3 and ≤6 on the 10-point scale.
• Female participant of childbearing potential must use one of the reliable methods of contraception during the investigation and agree not to change it during the study;
• A woman is considered of childbearing potential unless she is:
• Postmenopausal for at least 12 months prior to screening visit;
• Without uterus and/or both ovaries;
• Has been surgically sterile for at least 6 months prior to Screening visit.
• Participant must agree to use only the designated products

You may not qualify if:

• Participant who is pregnant or who is breast feeding;
• Participant receiving hormone replacement therapy (HRT).
• Participant who smokes more than two cigarettes per week;
• Participant whose alcohol intake exceeds 2 drinks per week;
• 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 gastro-intestinal malabsorption such as celiac disease, Crohn's disease, lactose intolerance;
• Participant with an history of sleeve or bypass;
• Participant with skin abnormalities (e.g., scars, excessive hair, tattooing) or any dermatosis (e.g., psoriasis, eczema, acne vulgaris) on the face which could interfere with the study;
• Participant with history of any severe disease or current condition which, in the opinion of the Investigator would put the participant at risk by participating in the study or would interfere significantly with the evaluation of study results
• Participant with known or suspected hypersensitivity to any ingredient(s) of the investigational products;
• Participants having undergone any aesthetic procedures (such as chemical peels, laser treatments, dermabrasions, injections, anti-ageing masks, hair implants, etc.) on the test areas within 6 months prior to the start of the study are excluded.
• 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 having use systemic corticosteroids, immunosuppressive drugs, or retinoids (oral or topical) within 3 months prior to study enrollment;
• Only for participants (20 in each group) who are willing to accept skin microbiopsies: The participant who has a contraindication to skin biopsies
• Participant impossible to contact in case of emergency;

Sponsors & Collaborators

• Vichy Laboratoires: lead
• CPCAD GIE: collaborator
• SKINPHARMA: collaborator

MeSH Terms

Interventions

Collagen

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Julie Faure

CONTACT

+33776112798; julie.faure@loreal.com

Claire Deloche-Bensmaine, phD

CONTACT

+33776112798; claire.deloche-bensmain@loreal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: products will be investigator masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-center, single-blind, randomized, parallel-group study involving 165 women with visible signs of skin ageing. Participants will be enrolled and randomized in equal proportions across three groups (55 participants per group) as follows: * Group 1: Combined oral collagen supplement + topical collagen serum; * Group 2: Oral collagen supplement alone; * Group 3: Topical collagen serum alone.

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 16, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share