Anti-Aging, Skin Aging
Conditions
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)
Interventions
OTHERDay Cream cosmetic product compared to untreated side
Applied once daily in the morning
OTHERNight cream cosmetic product compared to untreated side
Applied once daily in the evening
OTHEREye cream cosmetic product compared to untreated side
Applied twice daily in the morning and in the evening around the eye area
OTHERSerum cosmetic product compared to untreated side
Applied twice daily in the morning and in the evening
Sponsors
proDERM GmbH
Amazentis SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 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 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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 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 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 |
Countries
Germany
Outcome results
None listed