Skin Mitochondrial Protection by R0090948A Active

September 28, 2026 updated by: L'Oreal

A Monocenter, Double-blind, Comparative, Controlled, Randomized Study to Evaluate the Effect of Active R0090948A at 1%, Compared to Vehicle, on Mitochondria With or Without UV Stress in Healthy Participants.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women between 35 and 45 years old, both included
  2. Participant with skin phototype III according to Fitzpatrick classification
  3. Uniform skin color all over the four zones (difference in ITA° between the 4 zones should not be more than 4°)
  4. Average ITA° (Individual Typologic Angle calculated value) on the back over the four zones between 28° and 41° at screening / inclusion visit
  5. Absence of freckles, naevi, hypo or hyper pigmented regions, hairs, marks of tanning and tatoo on the investigational area on the lower back
  6. 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
  7. Female participant of childbearing potential or pre-menopausal woman (with absence of menstruations for less than one year) willing to undergo urine pregnancy test
  8. Participant with negative blood test results for Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies (anti-HCV), and HIV, performed within 2 weeks prior to inclusion, with results documented in the participant's records.
  9. Participant accepting to undergo 4 biopsies (3mm diameter punch) on the back
  10. Participant willing and able to fulfill the study requirements and schedule
  11. Participant informed about the study objectives and procedures, and able to understand them
  12. Participant who has given written informed consent form

Exclusion Criteria:

  1. Participant who is pregnant or who is planning to become pregnant during the study
  2. Menopausal woman with absence of menstruation for more than one year
  3. Participant having changed hormonal treatment (contraception...) within the last 3 months or having to planned to change during the study
  4. 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
  5. Participant with positive results on at least one of the following viruses: Hepatitis B or Hepatitis C or HIV test.
  6. 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…)
  7. Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study
  8. Having used sunbeds or excessive sun exposure of the investigational area within the 3 months before inclusion
  9. Having sunburn (erythema) on the back
  10. Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems)
  11. History of skin cancer
  12. History of abnormal response to sun
  13. Presence of recent suntan (according to Investigator opinion) or photo-test marks
  14. Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator
  15. Having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, antihypertensive, antibiotics -e.g. quinolone, tetracycline, thiazides, fluoroquinolones-)
  16. Having used within the month before inclusion any medication known to cause abnormal responses to UV exposure (e.g. vitamin A derivatives, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study
  17. Having used within the 3 months before inclusion any depigmenting / whitening or pro-pigmenting topical treatments, or having planned to use these treatments during the study
  18. 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
  19. Having planned to perform intensive sport (> 5 hours per week) or swim during the study
  20. Participant who declares to be deprived of freedom by administrative or legal decision
  21. Participant who cannot be contacted by telephone in case of emergency
  22. Participant having participated within the 30 days before inclusion or currently participating in another clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vehicle without UV

Application of vehicle without any UVA1 exposure
Procedure: Skin biopsy

3mm punch skin biopsies on four zones on the back of participant
Experimental: Vehicle with UV

Application of vehicle with a single 50J/cm2 UVA1 exposure
Procedure: Skin biopsy

3mm punch skin biopsies on four zones on the back of participant
Experimental: Active without UV

Application of active with a single 50J/cm2 UVA1 exposure
Procedure: Skin biopsy

3mm punch skin biopsies on four zones on the back of participant
Experimental: Active with UV

Application of active without UVA1 exposure
Procedure: Skin biopsy

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Transmission Electron Microscopy analyses
Time Frame: 24hours after Ultra Violet rays exposure

Transmission Electron Microscopy images will be acquired on the 3mm punch biopsies
24hours after Ultra Violet rays exposure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immunostaining with TOMM20 analyses
Time Frame: 24hours after Ultra Violet rays exposure

Immunostaining (TOMM20) images will be acquired with 3mm punch biopsies
24hours after Ultra Violet rays exposure
Proteomic and Metabolomic analyses
Time Frame: 24hours after Ultra Violet rays exposure versus baseline

Proteomic and Metabolomic analyses will be done trough tape stripping assessment.
24hours after Ultra Violet rays exposure versus baseline
pigmentation assessment
Time Frame: 24h and one week after UV exposure versus baseline

Skin pigmentation will be assessed through chromametric measurements and clinical scoring.
24h and one week after UV exposure versus baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
L'Oreal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACR_ROMY_26-09424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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