Skin Mitochondrial Protection by R0090948A Active

NCT07853027 | Not Yet Recruiting DMC

• 1 other identifier: ACR_ROMY_26-09424
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study intends to evaluate the skin longevity through mitochondria protection efficacy of cosmetic products after 3 months of product application, under UV exposures or not, followed by skin biopsies. Primary objective: \- To assess the efficacy of the investigational active in skin mitochondria protection, after twelve weeks of product application with or without UV stress, by morphological and texture parameters measurements Secondary objectives:

• To assess efficacy on other biomarkers of skin mitochondria with biopsies histological analyses
• To assess efficacy by skin colorimetric measurements
• To assess efficacy by visual scoring of skin pigmentation and erythema
• To assess efficacy by skin untargeted full proteomic analysis
• To assess efficacy by skin metabolomic analysis Safety: to follow the Adverse Events all along the study

Conditions

Skin Ageing

Keywords

Skin mitochondria; UVA1 exposure; TEM analyses; TOMM20 analyses

Outcome Measures

Primary Outcomes (1)

• Transmission Electron Microscopy analyses

  Transmission Electron Microscopy images will be acquired on the 3mm punch biopsies

  24hours after Ultra Violet rays exposure

Secondary Outcomes (3)

• Immunostaining with TOMM20 analyses

  24hours after Ultra Violet rays exposure

• Proteomic and Metabolomic analyses

  24hours after Ultra Violet rays exposure versus baseline

• pigmentation assessment

  24h and one week after UV exposure versus baseline

Study Arms (4)

Vehicle without UV

EXPERIMENTAL

Application of vehicle without any UVA1 exposure

Procedure: Skin biopsy

Vehicle with UV

EXPERIMENTAL

Application of vehicle with a single 50J/cm2 UVA1 exposure

Procedure: Skin biopsy

Active without UV

EXPERIMENTAL

Application of active with a single 50J/cm2 UVA1 exposure

Procedure: Skin biopsy

Active with UV

EXPERIMENTAL

Application of active without UVA1 exposure

Procedure: Skin biopsy

Interventions

Skin biopsy PROCEDURE

3mm punch skin biopsies on four zones on the back of participant

Active with UV; Active without UV; Vehicle with UV; Vehicle without UV

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 35 and 45 years old, both included
• Participant with skin phototype III according to Fitzpatrick classification
• Uniform skin color all over the four zones (difference in ITA° between the 4 zones should not be more than 4°)
• Absence of freckles, naevi, hypo or hyper pigmented regions, hairs, marks of tanning and tatoo on the investigational area on the lower back
• Female of childbearing potential, who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study, and throughout the study
• Female participant of childbearing potential or pre-menopausal woman (with absence of menstruations for less than one year) willing to undergo urine pregnancy test
• Participant accepting to undergo 4 biopsies (3mm diameter punch) on the back
• Participant willing and able to fulfill the study requirements and schedule
• Participant informed about the study objectives and procedures, and able to understand them
• Participant who has given written informed consent form

You may not qualify if:

• Participant who is pregnant or who is planning to become pregnant during the study
• Menopausal woman with absence of menstruation for more than one year
• Participant having changed hormonal treatment (contraception...) within the last 3 months or having to planned to change during the study
• Participant with bleeding disorders, bleeding with previous surgery and eventual use of drugs known to interfere with hemostasis which could impact on the biopsy collection
• Participant with positive results on at least one of the following viruses: Hepatitis B or Hepatitis C or HIV test.
• Any contra-indication for biopsies: medical history of allergy, hypersensitivity or any serious reaction to local anaesthesia, local antibiotic \& antiseptic, history of healing defects (hypertrophy, keloids…)
• Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study
• Having sunburn (erythema) on the back
• Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems)
• History of skin cancer
• History of abnormal response to sun
• Presence of recent suntan (according to Investigator opinion) or photo-test marks
• Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator
• Having used, within the past 6 months, any physical treatment including laser or phototherapy (PUVA, IPL, PDT…) on the investigational area, or having planned to use these treatments during the study
• Having planned to perform intensive sport (\> 5 hours per week) or swim during the study

Sponsors & Collaborators

• L'Oreal: lead

Related Publications (2)

• He H, Xiong L, Jian L, Li L, Wu Y, Qiao S. Role of mitochondria on UV-induced skin damage and molecular mechanisms of active chemical compounds targeting mitochondria. J Photochem Photobiol B. 2022 Jul;232:112464. doi: 10.1016/j.jphotobiol.2022.112464. Epub 2022 May 13.

  PMID: 35597147 BACKGROUND

• Yuan X, Li H, Lee JS, Lee DH. Role of Mitochondrial Dysfunction in UV-Induced Photoaging and Skin Cancers. Exp Dermatol. 2025 May;34(5):e70114. doi: 10.1111/exd.70114.

  PMID: 40318065 BACKGROUND

Central Study Contacts

de Dormael Romain, MsC

CONTACT

+33609556837; romain.dedormael@loreal.com

Study Design

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

Model Details: Monocenter, double blind, randomized design, intra-individual comparison with four different product applied on the same participant.

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: October 1, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09