NCT06619457

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

September 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2024

Completed
Last Updated

April 3, 2025

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

September 25, 2024

Last Update Submit

April 2, 2025

Conditions

Skin Aging

Keywords

MitochondriaUrolithin AMitopureAging

Outcome Measures

Primary Outcomes (2)

  • Anti-wrinkle efficacy

    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).

    12 weeks

  • Skin Biological age

    DNA methylation patterns analysis (epigenetics) by skin tape stripping (D-Squames)

    12-weeks

Secondary Outcomes (5)

  • Skin hydration

    12 weeks

  • Transepidermal Water Loss (TEWL)

    12 weeks

  • Mitochondrial morphology in skin

    12 weeks

  • Photodocumentation of skin health

    12 weeks

  • Subjective questionnaire

    12 weeks

Study Arms (2)

Placebo Cream

EXPERIMENTAL
Other: Placebo Cream

Active Moisturizing Cream

EXPERIMENTAL
Other: Mitopure (Urolithin A) Cream

Interventions

Mitopure (Urolithin A) CreamOTHER

cosmetic cream to be applied topically on face and forearms twice/daily using split/face design

Active Moisturizing Cream
Placebo CreamOTHER

cosmetic cream to be applied topically on face and forearms twice/daily using split/face design

Placebo Cream

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 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

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
  • 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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS proderm GmbH

Schenefeld, Hamburg, 22869, Germany

Location

MeSH Terms

Interventions

3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one

Study Officials

  • Katrin Unbereit, PhD

    SGS proderm GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2024

First Posted

October 1, 2024

Study Start

September 25, 2024

Primary Completion

December 12, 2024

Study Completion

December 12, 2024

Last Updated

April 3, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)