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

NCT05473832 | Completed

• 1 other identifier: 22.0229-39
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 (8)

• 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 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

Study Arms (4)

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

Interventions

Day Cream cosmetic product compared to untreated side OTHER

Applied once daily in the morning

Group 1

Night cream cosmetic product compared to untreated side OTHER

Applied once daily in the evening

Group 2

Eye cream cosmetic product compared to untreated side OTHER

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

Group 3

Serum cosmetic product compared to untreated side OTHER

Applied twice daily in the morning and in the evening

Group 4

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Amazentis SA: lead
• proDERM GmbH: collaborator

Study Sites (1)

proderm GmbH

Schenefeld, Germany

Location

Study Officials

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

  proDERM GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 26, 2022
• Study Start: July 13, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 17, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)