NCT05300984

Brief Summary

The aim of this study is to investigate the effect of cosmetic products with two different concentrations of the active on skin aging and in acting on the mitochondrial health of skin in comparison to a placebo product.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

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

Study Start

First participant enrolled

March 15, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2022

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

March 19, 2022

Last Update Submit

April 5, 2023

Conditions

Skin Aging

Keywords

Mitochondria, Aging

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks

    8 weeks

  • Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 8-weeks

    8 weeks

Secondary Outcomes (8)

  • Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2-weeks

    2-weeks

  • Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2 and 8 weeks

    8 weeks

  • Change from baseline in pigmentation (assessed on skin color by Spectrophotometer) after 2 and 8 weeks

    8 weeks

  • Change from baseline in skin firmness by Cutometer [mm] after 2 and 8 weeks

    8 weeks

  • Change from baseline in skin elasticity by Cutometer after 2 and 8 weeks

    8 weeks

  • +3 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL
Other: Topical Placebo CreamOther: Topical Cream with 0.5% Active

Group 2

EXPERIMENTAL
Other: Topical Placebo CreamOther: Topical Cream with 1% Active

Interventions

Topical Placebo CreamOTHER

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

Group 1Group 2
Topical Cream with 0.5% ActiveOTHER

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

Group 1
Topical Cream with 1% ActiveOTHER

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

Group 2

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale(Gender-based eligibility)
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
  • From 50 to 75 years of age
  • Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
  • Healthy skin in the test areas
  • Vaccination of tetanus within the last 10 years (for biopsy sub group)

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
  • Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
  • Diabetes mellitus (type 1 and 2)
  • Documented allergies to cosmetic products and/or ingredients, skin care and/or skin cleansing products
  • Intolerability against adhesive dressing (e.g. acrylate)
  • Active skin disease at the test area
  • Regular use of tanning beds
  • Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
  • Any topical medication at the test area within the last 3 days prior to the start 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

proderm GmbH

Schenefeld, Germany

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD

    proDERM GmbH

    STUDY CHAIR

  • Dr. rer. nat. Sabrina Laing, MD

    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
Model Details: Split face/arm design
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2022

First Posted

March 29, 2022

Study Start

March 15, 2022

Primary Completion

May 10, 2022

Study Completion

May 16, 2022

Last Updated

April 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)