Skin Aging Clinical Trial
Official title:
Evaluation of the Anti-aging Efficacy of Four Cosmetic Products
Verified date | April 2023 |
Source | Amazentis SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 144 |
Est. completion date | October 17, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | proderm GmbH | Schenefeld |
Lead Sponsor | Collaborator |
---|---|
Amazentis SA | proDERM GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks | 8-weeks | ||
Secondary | Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks | 8-weeks | ||
Secondary | Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2, 4 and 8 weeks | 8-weeks | ||
Secondary | Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 8-weeks | 8-weeks | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks | 8-weeks |
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