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

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

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age45-60

SponsorVichy Laboratoires

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Oral collagen
Dietary supplement
combination of oral collagen supplementation and topical application of collagen serum
topical application of collagen serum
Other intervention
topical application of collagen serum

Treatment groups

165 Participants

are divided into 3 treatment groups

Group A: Group 1: Combined oral collagen supplement + topical collagen serumExperimental treatment 2 interventions

Group B: Group 2: Oral collagen supplement aloneActive comparator 1 intervention

Group C: Group 3: Topical collagen serum aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Baseline, Week 3, Week 7, Week 13

Secondary outcomes

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

Time frame

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

Time frame

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

Time frame

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

Time frame

baseline, week 3, week 7, week 13

Other outcomes

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

according to Kislevitz M,, Lu KB, , Wamsley C, , Hoopman J, , Kenkel J et Akgul Y, Novel Use of Non-Invasive Devices and Microbiopsies to Assess Facial Skin Rejuvenation Following Laser Treatment. . Lasers Surg Med. 2020 Nov;52(9):822-830. doi: 10.1002/lsm.23233. Epub 2020 Mar.

Time frame

baseline, week 13

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vichy Laboratoires

Lead sponsor

CPCAD GIE

Collaborator

SKINPHARMA

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: