Cleansing Efficacy of Cosmetic Product

NCT06956625 | Completed

• 1 other identifier: 25.0054-60
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the cleansing effect of one cosmetic product containing Mitopure against a particular matter model pollutant in comparison to an untreated control.

Conditions

Healthy Skin

Outcome Measures

Primary Outcomes (1)

• Luminosity (L)

  Luminosity in test area assessed by HiRIS (High Resolution Imaging System) image analysis will be used to quantify cleaning efficacy.

  Before pollutant application (t0), immediately after evaporation of the applied pollutant (t1), and 20 minutes after product rinse-off (t2)

Study Arms (2)

Cosmetic product

EXPERIMENTAL

Test area topically washed with cleanser containing Mitopure

Other: Topical cosmetic cleanser

Tap water (control)

OTHER

Test area topically washed with tap water

Other: Topical tap water

Interventions

Topical cosmetic cleanser OTHER

After applying the model pollutant, the test area will be topically cleaned with the active cosmetic cleanser with Mitopure.

Cosmetic product

Topical tap water OTHER

After applying the model pollutant, the test area will be topically cleaned with tap water (control).

Tap water (control)

Eligibility Criteria

• Age: 18 Years - 70 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/or male
• From 18 to 70 years of age
• Healthy skin in the test area
• Skin type on Fitzpatrick scale: I, II or III

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
• Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
• Active skin disease at the test area
• Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
• Any topical medication at the test area within the last 4 weeks prior to the start of the study and during the study
• Documented allergies to cosmetic products and/or ingredients

Sponsors & Collaborators

• Amazentis SA: lead
• SGS proderm GmbH: collaborator

Study Sites (1)

SGS proderm GmbH

Schenefeld, Germany

Location

Study Officials

• Dr Katrin Unbereit

  SGS proderm GmbH

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Two test areas will be defined on both forearms. Area 1 will be located on the right forearm; Area 2 will be located on the left forearm. Treatments will be randomly and balanced assigned to the test areas.

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 4, 2025
• Study Start: May 8, 2025
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)