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

NCT ID: NCT05473832

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2022-10-17

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)

Conditions

Anti-Aging; Skin Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1

Group Type: EXPERIMENTAL

Day Cream cosmetic product compared to untreated side

Intervention Type: OTHER

Applied once daily in the morning

Group 2

Group Type: EXPERIMENTAL

Night cream cosmetic product compared to untreated side

Intervention Type: OTHER

Applied once daily in the evening

Group 3

Group Type: EXPERIMENTAL

Eye cream cosmetic product compared to untreated side

Intervention Type: OTHER

Applied twice daily in the morning and in the evening around the eye area

Group 4

Group Type: EXPERIMENTAL

Serum cosmetic product compared to untreated side

Intervention Type: OTHER

Applied twice daily in the morning and in the evening

Interventions

Day Cream cosmetic product compared to untreated side

Applied once daily in the morning

Intervention Type: OTHER

Night cream cosmetic product compared to untreated side

Applied once daily in the evening

Intervention Type: OTHER

Eye cream cosmetic product compared to untreated side

Applied twice daily in the morning and in the evening around the eye area

Intervention Type: OTHER

Serum cosmetic product compared to untreated side

Applied twice daily in the morning and in the evening

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

proDERM GmbH

INDUSTRY

Sponsor Role: collaborator

Amazentis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Dr. med. Klaus-Peter Wilhelm, MD

Role: STUDY_CHAIR

proDERM GmbH

Locations

proderm GmbH

Schenefeld, , Germany

Countries

Germany

Other Identifiers

22.0229-39

Identifier Type: -

Identifier Source: org_study_id