Skin Cell Regeneration Efficacy of Cosmetic Product

NCT07096466 | Completed

• 1 other identifier: 25.0055-25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Skin

Outcome Measures

Primary Outcomes (1)

• Skin cell regeneration quantified by change in skin color measured by Chromameter (unit of measure: Individual Typological Angle; ITA°)

  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.

  14 days

Secondary Outcomes (3)

• Skin hydration

  14 days

• Skin barrier function

  14 days

• Product traits

  14 days

Study Arms (5)

Untreated, stained forearm

EXPERIMENTAL

On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will not be applied for two weeks to the volar forearm test area.

Other: DHA stain; Other: No cosmetic product application - forearm

Treated, stained forearm

EXPERIMENTAL

On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area.

Other: DHA stain; Other: Cosmetic product application - forearm

Untreated, unstained forearm

EXPERIMENTAL

On day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will not be applied for two weeks to the volar forearm test area.

Other: No DHA stain; Other: No cosmetic product application - forearm

Treated, unstained forearm

EXPERIMENTAL

On day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area.

Other: No DHA stain; Other: Cosmetic product application - forearm

Facial treatment

EXPERIMENTAL

For two weeks on the face (excluding eye area), a cleansing cosmetic product containing Mitopure will be applied twice daily, and the cosmetic test product (that is used on forearms) will be applied once daily.

Other: Cosmetic products application - face

Interventions

DHA stain OTHER

On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours)

Treated, stained forearm; Untreated, stained forearm

No DHA stain OTHER

On day 1, the volar forearm test area will not undergo DHA staining.

Treated, unstained forearm; Untreated, unstained forearm

Cosmetic product application - forearm OTHER

The cosmetic product will be applied twice daily for two weeks to the volar forearm test area.

Treated, stained forearm; Treated, unstained forearm

No cosmetic product application - forearm OTHER

The cosmetic product will not be applied for two weeks to the volar forearm test area.

Untreated, stained forearm; Untreated, unstained forearm

Cosmetic products application - face OTHER

For two weeks on the face (excluding eye area), a cleansing cosmetic product containing Mitopure will be applied twice daily, and the cosmetic test product (that is used on forearms) will be applied once daily.

Facial treatment

Eligibility Criteria

• Age: 18 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/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

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
• 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

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: On each volar forearm two test areas (each sized 3 cm x 3 cm) will be defined. Test area 1 will denote the lower right, 2 the upper right forearm. Test areas 3 and 4 on left forearm will be allocated accordingly. Each forearm test area will undergo one of four treatments (stained or unstained with DHA; and treated or untreated with cosmetic product) so all four treatments are experienced by every participant. Overall, the four treatment conditions (one treatment per test area) will be: A) Untreated with cosmetic product, stained with DHA (negative control) B) Treated with cosmetic product, stained with DHA C) Untreated with cosmetic product, unstained (negative control) D) Treated with cosmetic product, unstained Treatments will be randomly and balanced assigned to the four volar forearm test areas. E) All participants will also apply two cosmetic products to the facial area.

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 31, 2025
• Study Start: June 23, 2025
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)