Cleansing Efficacy of Cosmetic Product (Cleanser)

Cleansing Efficacy of Cosmetic Products - Particular Matter Model

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.

Study Overview

• Status: Completed
• Conditions: Healthy Skin
• Intervention / Treatment: Other: Topical cosmetic cleanser; Other: Topical tap water

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schenefeld, Germany
    • SGS proderm GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cosmetic product; Test area topically washed with cleanser containing Mitopure	Other: Topical cosmetic cleanser; After applying the model pollutant, the test area will be topically cleaned with the active cosmetic cleanser with Mitopure.
Other: Tap water (control); Test area topically washed with tap water	Other: Topical tap water; After applying the model pollutant, the test area will be topically cleaned with tap water (control).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Amazentis SA
• Collaborators: SGS proderm GmbH
• Investigators: Principal Investigator: Dr Katrin Unbereit, SGS proderm GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2025
• Primary Completion (Actual): May 9, 2025
• Study Completion (Actual): May 9, 2025

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 25.0054-60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No