Evaluation of Oral Collagen Peptides on Skin Barrier Function in Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-70
SponsorCentre de Pharmacologie Clinique Applique a la Dermatologie
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Investigational Product 1
Dietary supplementThis product is going to be concentrated at 2000mg
Investigational Product 2
Dietary supplementThis product is going to be concentrated at 5000mg
Placebo
Dietary supplementThis product is going to be flavoured water
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Investigational product 1Active comparator 1 intervention
Group C: Investigational product 2Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
from baseline until the end of treatment at T3 monthsSecondary 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
Time frame
From the baseline until the end of the treatment at T3 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre de Pharmacologie Clinique Applique a la Dermatologie
Lead sponsor
Rousselot BVBA
Collaborator
Source ClinicalTrials.gov