CClinicalTrials.gg
Not yet recruitingNCT07853027Updated Oct 1, 2026

Skin Mitochondrial Protection by R0090948A Active

An interventional study of Skin biopsy in Skin Ageing, sponsored by L'Oreal. Not yet recruiting. Open to female participants aged 35 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by L'Oreal · Not applicable, Interventional, and Treatment

Updated Oct 1, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
35 Years to 45 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Skin Ageing

Keywords

  • Skin mitochondria
  • UVA1 exposure
  • TEM analyses
  • TOMM20 analyses
03

In context

Lead sponsor

L'Oreal is the lead sponsor of 25 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
13 participants (estimated)

Study arms

  • Experimental
    Vehicle without UV

    Application of vehicle without any UVA1 exposure

    Procedure: Skin biopsy

  • Experimental
    Vehicle with UV

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

    Procedure: Skin biopsy

  • Experimental
    Active without UV

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

    Procedure: Skin biopsy

  • Experimental
    Active with UV

    Application of active without UVA1 exposure

    Procedure: Skin biopsy

Interventions

  • ProcedureSkin biopsy

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

06

What researchers measure

Primary outcomes

  1. Transmission Electron Microscopy analyses

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

    Time frame: 24hours after Ultra Violet rays exposure

Secondary outcomes

  1. Immunostaining with TOMM20 analyses

    Immunostaining (TOMM20) images will be acquired with 3mm punch biopsies

    Time frame: 24hours after Ultra Violet rays exposure

  2. Proteomic and Metabolomic analyses

    Proteomic and Metabolomic analyses will be done trough tape stripping assessment.

    Time frame: 24hours after Ultra Violet rays exposure versus baseline

  3. pigmentation assessment

    Skin pigmentation will be assessed through chromametric measurements and clinical scoring.

    Time frame: 24h and one week after UV exposure versus baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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 35597147 ↗
  • 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. PubMed 40318065 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 16, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07853027
Lead sponsor
L'Oreal
Responsible party
Sponsor
First posted
Oct 1, 2026
Start date
Sep 28, 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Oct 1, 2026

Study contacts

de Dormael Romain, MsC
Contact
romain.dedormael@loreal.com
+33609556837

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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