Clinical trial NCT05473832: Evaluation of the Anti-aging Efficacy of Four Skin Health Products
Official title: Evaluation of the Anti-aging Efficacy of Four Cosmetic Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anti-Aging
Skin Aging
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
Collaborators: name: proDERM GmbH
First posted: 2022-07-26
Enrollment: 144
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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)


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

Primary outcomes:
measure: 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).
timeFrame: 8-weeks
Secondary outcomes:
measure: Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks
timeFrame: 8-weeks
measure: Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks
timeFrame: 8-weeks
measure: Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2, 4 and 8 weeks
timeFrame: 8-weeks
measure: Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 8-weeks
timeFrame: 8-weeks
measure: 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
timeFrame: 8-weeks
measure: 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
timeFrame: 8-weeks
measure: 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)
timeFrame: 8-weeks
measure: Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: proderm GmbH
Study officials:
affiliation: proDERM GmbH
name: Prof. Dr. med. Klaus-Peter Wilhelm, MD
role: STUDY_CHAIR
References: