Skip to main content
OpenTrials
Completed

NCT Number: NCT07517887

Anti-aging Efficacy Study on One Cosmetic Product Containing Mitopure

The aim of this study is to investigate the impact of a topical product on skin health and aging

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SGS proderm GmbH

Schenefeld, 22869, 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
  • Written Informed Consent for the use of the images for marketing purposes applies to subgroup participants of study 26.0112.
  • Willingness to actively participate in the study and to come to the scheduled visits
  • Female
  • Male, approximately 10 to 15% with little facial hair
  • From 45 to 65 years of age
  • Healthy skin in the test areas
  • Visible wrinkles in the face (grade 3 to 6 according to proderm wrinkle score)

Exclusion criteria

  • Female participants: 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
  • Active skin disease at the test area
  • Documented allergies to face/eye care products or their ingredients
  • Diabetes mellitus
  • Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
  • One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases
  • Epilepsy
  • Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation
  • Regular use of tanning beds within the last 6 weeks prior to the start of the study
  • Any topical medication at the test area within the last 3 days prior to the start of the study
  • Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study and throughout the entire course of the study that in the opinion of the investigator may affect the outcome of the study
  • Therapy with antibiotics within the last 2 weeks prior to the start of the study and throughout the entire course of the study that in the opinion of the investigator may affect the outcome of the study
  • Cosmetic surgery procedure in the test area (e.g. laser, facelift) within the last 2 years and throughout the entire course of the study
  • Cosmetic surgery treatments in the test area, e.g. IPL (Intensed Pulsed Light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and throughout the entire course of the study
  • Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study and throughout the entire course of the study

Treatment and study plan

Skin care product

Other

The cosmetic skin care product will be applied twice daily to half of the face

Primary outcomes

  1. Skin hydration

    Time frame: 8 weeks

    Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 2 and 8 weeks

Secondary outcomes

  1. Anti-wrinkle efficacy

    Time frame: 8 weeks

    Change from baseline in anti-wrinkles efficacy (assessed on three-dimensional structure of the wrinkles in the periorbital regions) after 2 and 8 weeks. Anti-wrinkle efficacy will be assessed using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).

  2. Skin barrier function

    Time frame: 8 weeks

    Change from baseline in skin barrier function (assessed onTransepidermal water loss (TEWL) by Tewameter [g/(m²h)]) after 2 and 8 weeks

  3. Skin firmness

    Time frame: 8 weeks

    Change from baseline in skin firmness (assessed by R0 (Uf) by Cutometer [mm]) after 2 and 8 weeks

  4. Skin elasticity

    Time frame: 8 weeks

    Change from baseline in skin elasticity (assessed by R7 (Ur/Uf) by Cutometer) after 2 and 8 weeks

  5. Clinical skin appearance

    Time frame: 8 weeks

    Change from baseline for skin appearance (assessed on VISIA-CR Image analysis) after 2 and 8 weeks

  6. Skin aging hallmarks

    Time frame: 8 weeks

    Change from baseline in skin hallmarks of aging (assessed on 22mm D-Squames® tape strips) after 2 and 8 weeks

  7. Product traits

    Time frame: 8 weeks

    Subjective evaluation of product traits assessed via questionnaire after 2 and 8 weeks.

    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;

    • = Rather agree;
    • = Fully agree
  8. Clinical Before-After Photography

    Time frame: 8 weeks

    An additional cohort of 15 participants will apply the test product to their full face. Trained graders will analyze images (assessed on VISIA-CR Image) to visually determine biological skin age after 2 and 8 weeks.

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • SGS proderm GmbH

Registry information

Official study title

Anti-aging Efficacy Study on One Cosmetic Product vs Untreated

Acronym: HCP-S1

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Jul 9, 2026

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.

Published trials that share one or more normalized conditions with this study.