Evaluation of the Anti-aging Efficacy of Four Skin Health Products

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the anti-wrinkle and anti-aging efficacy of four different cosmetic products compared to an untreated control (split-face study design)

Official Title
-----------------
Evaluation of the Anti-aging Efficacy of Four Cosmetic Products

Conditions
-----------------
Anti-Aging, Skin Aging

Intervention / Treatment
-----------------
* Other: Day Cream cosmetic product compared to untreated side
* Other: Night cream cosmetic product compared to untreated side
* Other: Eye cream cosmetic product compared to untreated side
* Other: Serum cosmetic product compared to untreated side


Participation Criteria
=================
Eligibility Criteria
-----------------
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 and male From 40 to 65 years of age BMI < 30 kg/m2 Healthy skin in the test areas Uniform skin color and no erythema or dark pigmentation in the test area Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2 Ethnicity: at least one Black, Asian and Hispanic subject per study 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 Active skin disease at the test area Documented allergies to face/eye care products 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 Sun-tanned skin (important for the subgroup of subjects planned for Raman measurements) Regular use of tanning beds Any topical medication at the test area within the last 7 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 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Other: Day Cream cosmetic product compared to untreated side<br>* Applied once daily in the morning<br>|
| Experimental: Group 2<br> | Other: Night cream cosmetic product compared to untreated side<br>* Applied once daily in the evening<br>|
| Experimental: Group 3<br> | Other: Eye cream cosmetic product compared to untreated side<br>* Applied twice daily in the morning and in the evening around the eye area<br>|
| Experimental: Group 4<br> | Other: Serum cosmetic product compared to untreated side<br>* Applied twice daily in the morning and in the evening<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra). |  | 8-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks |  | 8-weeks | 
| Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks |  | 8-weeks | 
| Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2, 4 and 8 weeks |  | 8-weeks | 
| Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 8-weeks |  | 8-weeks | 
| Change from baseline in ceramides by Raman Spectroscopy [a.u.] on a subgroup of n=12 subjects per test product group after 2, 4 and 8 weeks |  | 8-weeks | 
| Change in Image grading (Photodocumentation via USR-Clip) for skin radiance (3 trained graders will rank each pair of images in a blinded fashion) after 2, 4 and 8 weeks |  | 8-weeks | 
| Change in wrinkle scores (Photodocumentation via USR-Clip) for anti-wrinkle efficacy (3 trained graders will rank each pair of images at the area of the crow feet's in a blinded manner) |  | 8-weeks | 
| Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks |  | 8-weeks |