Anti-aging Efficacy Study on One Cosmetic Product Containing Mitopure

NCT07517887 | Completed

• 1 other identifier: 26.0076-23 26.0112-23
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aging; Wrinkle Appearance

Outcome Measures

Primary Outcomes (1)

• Skin hydration

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

  8 weeks

Secondary Outcomes (8)

• Anti-wrinkle efficacy

  8 weeks

• Skin barrier function

  8 weeks

• Skin firmness

  8 weeks

• Skin elasticity

  8 weeks

• Clinical skin appearance

  8 weeks

Study Arms (2)

Cosmetic routine

EXPERIMENTAL

The "cosmetic routine" arm will apply the skin care product

Other: Skin care product

Untreated control

NO INTERVENTION

The "Untreated control" arm will not apply the skin care product

Interventions

Skin care product OTHER

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

Cosmetic routine

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• SGS proderm GmbH: collaborator
• Amazentis SA: lead

Study Sites (1)

SGS proderm GmbH

Schenefeld, 22869, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Double (Outcomes Assessor)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split-face design. Subjects will be divided equally in 2 treatment groups (topical product or untreated). Treatments will be randomly and balanced assigned to left and right test area.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 8, 2026
• Study Start: April 22, 2026
• Primary Completion: June 19, 2026
• Study Completion: June 19, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)