Skin Cell Regeneration Efficacy of Cosmetic Product

Not Applicable

Completed

• Conditions: Healthy Skin

• Registration Number: NCT07096466
• Lead Sponsor: Amazentis SA

Brief Summary

The objective of the study is to investigate the effect of one cosmetic product (exfoliator) containing Mitopure on the skin cell regeneration as well as on the skin hydration and skin barrier function in comparison to an untreated control area on the volar forearms.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-23
• Status Verified: 2025-07
• Primary Completion: 2025-07-09
• Study Completion: 2025-07-09
• Study First Submitted: 2025-07-18
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 65 years of age
• Healthy skin in the test area
• Uniform skin color in the test area
• Fitzpatrick I-III
• Able to read and follow directions as outlined in the protocol

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
• Insulin-dependent diabetes mellitus (type 1 and 2)
• Documented allergies to cosmetic products and/or ingredients,
• Documented allergies to plaster systems or tape adhesives
• Active skin disease at the test area like acute dermatitis, that requires actual topical medication on the test area and/or systemic drug treatment according to a physician
• Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
• All kinds of beard (except a moustache) during the whole study
• Any topical medication at the test area within the last 3 days prior to the start of the study and throughout the entire course of the study
• Topical medication with anti-inflammatories, antihistamines within 1 week prior to the start of the study
• Topical medication with Immuno-suppressive medication within 2 weeks prior to the start of the study
• Systemic (oral) medication with Antibiotic (except penicillin) or anti-inflammatory steroids within 4 weeks prior to the start of the study and throughout the entire course of the study
• Systemic (oral) medication with anti-inflammatory non-steroids within 2 weeks prior to the start of the study and throughout the entire course of the study
• Phototherapy within 4 weeks prior to the start of the study and throughout the entire course of the study
• Systemic (oral) medication with retinoids within 6 months prior to the start of the study and throughout the entire course of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Skin cell regeneration quantified by change in skin color measured by Chromameter (unit of measure: Individual Typological Angle; ITA°)	14 days	Skin cell regeneration is quantified by the change in skin colour. Skin colour is measured with the Chromameter instrument (skin colour unit of measure: Individual Typological Angle \[ITA°\]). Therefore, skin cell regeneration is measured by the change in ITA°, such that a larger positive change in ITA° represents improved skin cell regeneration. Skin cell regeneration will be calculated 4, 8, 11, and 14 days after baseline.

Secondary Outcome Measures

Name	Time	Method
Skin hydration	14 days	Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 14 days.
Skin barrier function	14 days	Change from baseline in skin barrier function (assessed on Transepidermal water loss (TEWL) by Tewameter \[g/(m²h)\]) after 14 days.
Product traits	14 days	Subjective evaluation of product traits assessed via questionnaire after 14 days. Product traits will be assessed by the subjects with a list of closed questions with the following predefined identical options to tick:-2 = Fully disagree; -1 = Rather disagree; 1 = Rather agree; 2 = Fully agree

Trial Locations

Locations (1)

SGS proderm GmbH; 🇩🇪 Schenefeld, Germany