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Completed

NCT Number: NCT07096466

Skin Cell Regeneration Efficacy of Cosmetic Product

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SGS proderm GmbH

Schenefeld, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

No DHA stain

Other

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

Cosmetic product application - forearm

Other

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

No cosmetic product application - forearm

Other

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

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Skin hydration

    Time frame: 14 days

    Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 14 days.

  2. Skin barrier function

    Time frame: 14 days

    Change from baseline in skin barrier function (assessed on Transepidermal water loss (TEWL) by Tewameter [g/(m²h)]) after 14 days.

  3. Product traits

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • SGS proderm GmbH

Registry information

Official study title

CELL REGENERATION EFFICACY

Acronym: Exfoliator

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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