Evaluation of the Anti-aging Efficacy of Four Skin Health... | NCT05473832

Status Module

Name	Class
proDERM GmbH	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group 1	Experimental	Other: Day Cream cosmetic product compared to untreated side
Group 2	Experimental	Other: Night cream cosmetic product compared to untreated side
Group 3	Experimental	Other: Eye cream cosmetic product compared to untreated side
Group 4	Experimental	Other: Serum cosmetic product compared to untreated side

Name	Type	Description	Arm Group Labels	Other Names
Day Cream cosmetic product compared to untreated side	Other	Applied once daily in the morning	Group 1

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

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