Evaluation of the Anti-aging Efficacy of a Novel Skin Health Product

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of cosmetic products with two different concentrations of the active on skin aging and in acting on the mitochondrial health of skin in comparison to a placebo product.

Official Title
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Evaluation of the Anti-aging Efficacy of a Novel Cosmetic Product

Conditions
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Skin Aging

Intervention / Treatment
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* Other: Topical Placebo Cream
* Other: Topical Cream with 0.5% Active
* Other: Topical Cream with 1% Active


Participation Criteria
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Eligibility Criteria
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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 50 to 75 years of age Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2 Healthy skin in the test areas Vaccination of tetanus within the last 10 years (for biopsy sub group) 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 Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years Diabetes mellitus (type 1 and 2) One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases Documented allergies to cosmetic products and/or ingredients, skin care and/or skin cleansing products Intolerability against adhesive dressing (e.g. acrylate) Active skin disease at the test area Regular use of tanning beds Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation Any topical medication at the test area within the last 3 days prior to the start 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 Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like paracetamol within the last 3 days prior to the start of the study Therapy with antibiotics within the last 2 weeks prior to the start of the study 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 Past cosmetic surgery procedure in the test area (e.g. laser, facelift) History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split face/arm design
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Other: Topical Placebo Cream<br>* cosmetic cream to be applied topically on face and forearms twice/daily using split/face design<br>Other: Topical Cream with 0.5% Active<br>* cosmetic cream to be applied topically on face and forearms twice/daily using split/face design<br>|
| Experimental: Group 2<br> | Other: Topical Placebo Cream<br>* cosmetic cream to be applied topically on face and forearms twice/daily using split/face design<br>Other: Topical Cream with 1% Active<br>* cosmetic cream to be applied topically on face and forearms twice/daily using split/face design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks |  | 8 weeks | 
| Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 8-weeks |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2-weeks |  | 2-weeks | 
| Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2 and 8 weeks |  | 8 weeks | 
| Change from baseline in pigmentation (assessed on skin color by Spectrophotometer) after 2 and 8 weeks |  | 8 weeks | 
| Change from baseline in skin firmness by Cutometer [mm] after 2 and 8 weeks |  | 8 weeks | 
| Change from baseline in skin elasticity by Cutometer after 2 and 8 weeks |  | 8 weeks | 
| Change from baseline in skin layer thickness and undulation index of DEJ (assessed on Line field confocal Optical Coherence Tomography Image analysis) after 8 weeks for both groups or after 2 and 8 weeks |  | 8 weeks | 
| Change from baseline for wrinkles and fine lines (assessed on Colorface Image analysis) after 2 and 8 weeks |  | 8 weeks | 
| Subjective Evaluation of product traits assessed via questionnaire after 2 and 8 weeks |  | 2 and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitochondria, Aging