---
title: Evaluation of the Anti-aging Efficacy of One Face Care Cosmetic Product
nct_id: NCT06619457
overall_status: COMPLETED
phase: NA
sponsor: Amazentis SA
study_type: INTERVENTIONAL
primary_condition: Skin Aging
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06619457.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06619457"
ct_last_update_post_date: 2025-04-03
last_seen_at: "2026-05-12T06:28:47.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of the Anti-aging Efficacy of One Face Care Cosmetic Product

**NCT ID:** [NCT06619457](https://clinicaltrials.gov/study/NCT06619457)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 36
- **Lead Sponsor:** Amazentis SA
- **Collaborators:** proDERM GmbH
- **Conditions:** Skin Aging
- **Start Date:** 2024-09-25
- **Completion Date:** 2024-12-12
- **CT.gov Last Update:** 2025-04-03

## Brief Summary

The purpose of this study is to evaluate the anti-wrinkle efficacy and effect on skin epigenetic and on mitochondrial morphology of a facial cosmetic product compared to a placebo

## Eligibility

- **Minimum age:** 50 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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 approximately 10% male (at least 4 male subjects)
* From 50 to 75 years of age
* Healthy skin in the test areas
* Visible wrinkles in the face (grade 3 to 6 according to SGS proderm scale)

For biopsy subpanel:

-Vaccination of tetanus within the last 10 years

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
* Active skin disease at the test area
* Documented allergies to face/eye care products
* 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
* 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) and/or within the last 7 days prior to the start of the study
* Therapy with antibiotics within the last 2 weeks prior to the start of the study
* Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
* Cosmetic surgery procedure 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/or 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

For biopsy subpanel:

* Regular medication with anti-coagulating drugs like Aspirin®, Macumar®, etc. (e.g. for thrombosis prophylaxis) within up to 15 days prior to the taking of the biopsies
* History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)
* Known intolerance to local anaesthetics
* Known Sensitivity to any dressing systems
```

## Arms

- **Placebo Cream** (EXPERIMENTAL)
- **Active Moisturizing Cream** (EXPERIMENTAL)

## Interventions

- **Mitopure (Urolithin A) Cream** (OTHER) — cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
- **Placebo Cream** (OTHER) — cosmetic cream to be applied topically on face and forearms twice/daily using split/face design

## Primary Outcomes

- **Anti-wrinkle efficacy** _(time frame: 12 weeks)_ — Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using AEVA. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
- **Skin Biological age** _(time frame: 12-weeks)_ — DNA methylation patterns analysis (epigenetics) by skin tape stripping (D-Squames)

## Secondary Outcomes

- **Skin hydration** _(time frame: 12 weeks)_
- **Transepidermal Water Loss (TEWL)** _(time frame: 12 weeks)_
- **Mitochondrial morphology in skin** _(time frame: 12 weeks)_
- **Photodocumentation of skin health** _(time frame: 12 weeks)_
- **Subjective questionnaire** _(time frame: 12 weeks)_

## Locations (1)

- SGS proderm GmbH, Schenefeld, Free and Hanseatic City of Hamburg, Germany

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sgs proderm gmbh|schenefeld|free and hanseatic city of hamburg|germany` — added _(2026-05-12)_

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