Skin AgeingNCT07853027
Skin Mitochondrial Protection by R0090948A Active
A study testing Skin biopsy in people with Skin Ageing, run by L'Oreal.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Skin Ageing
- What is being tested?
- Skin biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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°)
- Average ITA° (Individual Typologic Angle calculated value) on the back over the four zones between 28° and 41° at screening / inclusion visit
- 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
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- 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 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.
- 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
Who cannot join
- 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…)
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- Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study
- Having used sunbeds or excessive sun exposure of the investigational area within the 3 months before inclusion
- 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 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-)
- 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
- 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
- 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
- Participant who declares to be deprived of freedom by administrative or legal decision
- Participant who cannot be contacted by telephone in case of emergency
- Participant having participated within the 30 days before inclusion or currently participating in another clinical study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
- 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
- Being tested
- Skin biopsy
- Keywords
- Skin mitochondria, UVA1 exposure, TEM analyses, TOMM20 analyses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyProcedure or surgery
3mm punch skin biopsies on four zones on the back of participant
| Study group | Role | What they receive |
|---|---|---|
| Vehicle without UV | Experimental | Application of vehicle without any UVA1 exposure Receives: Procedure: Skin biopsy |
| Vehicle with UV | Experimental | Application of vehicle with a single 50J/cm2 UVA1 exposure Receives: Procedure: Skin biopsy |
| Active without UV | Experimental | Application of active with a single 50J/cm2 UVA1 exposure Receives: Procedure: Skin biopsy |
| Active with UV | Experimental | Application of active without UVA1 exposure Receives: Procedure: Skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transmission Electron Microscopy analyses
Transmission Electron Microscopy images will be acquired on the 3mm punch biopsies
Measured: 24hours after Ultra Violet rays exposure
Secondary outcomes (3)
Immunostaining with TOMM20 analyses
Immunostaining (TOMM20) images will be acquired with 3mm punch biopsies
Measured: 24hours after Ultra Violet rays exposure
Proteomic and Metabolomic analyses
Proteomic and Metabolomic analyses will be done trough tape stripping assessment.
Measured: 24hours after Ultra Violet rays exposure versus baseline
pigmentation assessment
Skin pigmentation will be assessed through chromametric measurements and clinical scoring.
Measured: 24h and one week after UV exposure versus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start28 Sep 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin AgeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocenter, double blind, randomized design, intra-individual comparison with four different product applied on the same participant.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853027
- Sponsor's protocol ID
- ACR_ROMY_26-09424
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35597147Yuan 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.
PubMed 40318065
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07853027
- Acronym / sponsor ID
- ACR_ROMY_26-09424
- Conditions
- Skin Ageing
- Keywords
- Skin mitochondria, UVA1 exposure, TEM analyses, TOMM20 analyses
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Monocenter, double blind, randomized design, intra-individual comparison with four different product applied on the same participant.
| Arm | Type | Receives |
|---|---|---|
| Vehicle without UV | Experimental | Procedure: Skin biopsyApplication of vehicle without any UVA1 exposure |
| Vehicle with UV | Experimental | Procedure: Skin biopsyApplication of vehicle with a single 50J/cm2 UVA1 exposure |
| Active without UV | Experimental | Procedure: Skin biopsyApplication of active with a single 50J/cm2 UVA1 exposure |
| Active with UV | Experimental | Procedure: Skin biopsyApplication of active without UVA1 exposure |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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°)
- Average ITA° (Individual Typologic Angle calculated value) on the back over the four zones between 28° and 41° at screening / inclusion visit
- Absence of freckles, naevi, hypo or hyper pigmented regions, hairs, marks of tanning and tatoo on the investigational area on the lower back
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsy3mm punch skin biopsies on four zones on the back of participant | Procedure or surgery | Active with UV, Active without UV, Vehicle with UV, Vehicle without UV |
Primary outcome
Transmission Electron Microscopy analyses
Time frame: 24hours after Ultra Violet rays exposure
Transmission Electron Microscopy images will be acquired on the 3mm punch biopsies
3 secondary outcomes
Immunostaining with TOMM20 analyses
Time frame: 24hours after Ultra Violet rays exposure
Proteomic and Metabolomic analyses
Time frame: 24hours after Ultra Violet rays exposure versus baseline
pigmentation assessment
Time frame: 24h and one week after UV exposure versus baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 35597147He 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.
- Background: PubMed 40318065Yuan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsy in people with Skin Ageing, run by L'Oreal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact de Dormael Romain, MsC (+33609556837, romain.dedormael@loreal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transmission Electron Microscopy analyses (time frame: 24hours after Ultra Violet rays exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07853027, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.