Aging, Wrinkle
Conditions
Brief summary
The aim of this study is to investigate the impact of a topical and an oral product alone and in combination compared to placebo on skin aging
Interventions
DIETARY_SUPPLEMENTFood Supplement active
The food supplement active (2 soft gels) will be consumed once per day with a large glass of water.
DIETARY_SUPPLEMENTFood supplement placebo
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water.
OTHERSkin care product active
The cosmetic skin care product active will be applied twice daily to half of the face and to one volar forearm.
OTHERSkin care product placebo
The cosmetic skin care product placebo will be applied twice daily to half of the face and to one volar forearm.
Sponsors
SGS proderm GmbH
Amazentis SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Split-face design. Subjects will be divided equally in 2 treatment groups (food supplement active or food supplement placebo). Group 1 will receive treatments A and B (food supplement active with cosmetic active on one volar forearm and one side of face and cosmetic placebo on the other volar forearm and side of face) and group 2 C and D (food supplement placebo with cosmetic active on one volar forearm and one side of face and cosmetic placebo on the other volar forearm and side of face). Treatments will be randomly and balanced assigned to left and right test area in each group.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Written Informed Consent to participate in the study * Willingness to actively participate in the study and to come to the scheduled visits * Female * From 40 to 70 years of age, in order to include sufficient subjects for the study, if necessary, the age may be gradually increased to 70 years or decreased to 40 years * Healthy skin in the test areas * Visible wrinkles in the face (grade 3 to 6 according to proderm wrinkle score) For biopsy subpanel: \- Vaccination of tetanus within the last 10 years
Exclusion criteria
* Female subjects: Pregnancy or lactation * Drug addicts, alcoholics * AIDS, HIV-positive or infectious hepatitis * Conditions which exclude a participation or might influence the test reaction/evaluation * Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area * Active skin disease at the test area * Documented allergies to face/eye care products and food supplements or their ingredients * Intake of dietary supplements within the last 3 months before the start of the study * Diabetes mellitus * Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years * One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases * Epilepsy * Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation * Regular use of tanning beds * Any topical medication at the test area within the last 3 days prior to the start of the study * Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) and/or within the last 7 days prior to the start of the study * Therapy with antibiotics within the last 2 weeks prior to the start of the study * Past cosmetic surgery procedure in the test area (e.g. laser, facelift) * Cosmetic surgery procedure in the test area, e.g. IPL (Intensed Pulsed Light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and/or throughout the entire course of the study * Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study For biopsy subpanel: * Regular medication with anti-coagulating drugs like Aspirin®, Macumar®, etc. (e.g. for thrombosis prophylaxis) within up to 15 days prior to the taking of the biopsies * History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar) * Known intolerance to local anaesthetics * Known Sensitivity to any dressing systems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-wrinkle efficacy | 12 weeks | Change from baseline in anti-wrinkles efficacy (assessed on three-dimensional structure of the wrinkles in the periorbital regions) after 6 and 12 weeks. Anti-wrinkle efficacy will be assessed using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin hydration | 12 weeks | Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 6 and 12 weeks |
| Skin firmness | 12 weeks | Change from baseline in skin firmness (assessed by R0 (Uf) by Cutometer \[mm\]) after 6 and 12 weeks |
| Skin elasticity | 12 weeks | Change from baseline in skin elasticity (assessed by R7 (Ur/Uf) by Cutometer) after 6 and 12 weeks |
| Skin barrier function | 12 weeks | Change from baseline in skin barrier function (assessed onTransepidermal water loss (TEWL) by Tewameter \[g/(m²h)\]) after 6 and 12 weeks |
| Skin aging hallmarks | 12 weeks | Change from baseline in skin hallmarks of aging (assessed on 3mm punch skin biopsies) after 12 weeks in a subpanel of participants |
| Product traits | 12 weeks | Subjective evaluation of product traits assessed via questionnaire after 6 and 12 weeks. Product traits will be assessed by the subjects with a list of closed questions with the following predefined identical options to tick: * 2 = Fully disagree; * 1 = Rather disagree; 1. = Rather agree; 2. = Fully agree |
| Wrinkles and fine lines | 12 weeks | Change from baseline for wrinkles and fine lines (assessed on VISIA-CR Image analysis) after 6 and 12 weeks |
Countries
Germany
Outcome results
None listed