Anti-aging Efficacy Study on One Cosmetic Product Containing Mitopure (HCP-S1)

Anti-aging Efficacy Study on One Cosmetic Product vs Untreated

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

Study Overview

• Status: Recruiting
• Conditions: Aging; Wrinkle Appearance
• Intervention / Treatment: Other: Skin care product

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brad Currier, PhD; Phone Number: +41215521274; Email: bcurrier@timeline.com
• Study Contact Backup: Name: Anurag Singh, MD, PhD; Email: asingh@amazentis.com

Study Locations

• Germany
  • Schenefeld, Germany, 22869
    • Recruiting
    • SGS proderm GmbH
    • Contact: Dr. rer. nat. Katrin Unbereit; Phone Number: +49 40 83935899; Email: HSinnecker@proderm.de

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cosmetic routine; The "cosmetic routine" arm will apply the skin care product	Other: Skin care product; The cosmetic skin care product will be applied twice daily to half of the face
No Intervention: Untreated control; The "Untreated control" arm will not apply the skin care product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin hydration	Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 2 and 8 weeks	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-wrinkle efficacy	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).	8 weeks
Skin barrier function	Change from baseline in skin barrier function (assessed onTransepidermal water loss (TEWL) by Tewameter [g/(m²h)]) after 2 and 8 weeks	8 weeks
Skin firmness	Change from baseline in skin firmness (assessed by R0 (Uf) by Cutometer [mm]) after 2 and 8 weeks	8 weeks
Skin elasticity	Change from baseline in skin elasticity (assessed by R7 (Ur/Uf) by Cutometer) after 2 and 8 weeks	8 weeks
Clinical skin appearance	Change from baseline for skin appearance (assessed on VISIA-CR Image analysis) after 2 and 8 weeks	8 weeks
Skin aging hallmarks	Change from baseline in skin hallmarks of aging (assessed on 22mm D-Squames® tape strips) after 2 and 8 weeks	8 weeks
Product traits	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 weeks
Clinical Before-After Photography	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.	8 weeks

Collaborators and Investigators

• Sponsor: Amazentis SA
• Collaborators: SGS proderm GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 26.0076-23 26.0112-23

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