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Skin Mitochondrial Protection by R0090948A Active

28 september 2026 uppdaterad av: 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

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

13

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

35 år till 45 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Vehicle without UV

Application of vehicle without any UVA1 exposure

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

Experimentell: Vehicle with UV

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

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

Experimentell: Active without UV

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

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

Experimentell: Active with UV

Application of active without UVA1 exposure

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Transmission Electron Microscopy analyses
Tidsram: 24hours after Ultra Violet rays exposure

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

24hours after Ultra Violet rays exposure

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Immunostaining with TOMM20 analyses
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

28 september 2026

Primärt slutförande (Beräknad)

1 april 2027

Avslutad studie (Beräknad)

1 april 2027

Studieregistreringsdatum

Först inskickad

22 september 2026

Först inskickad som uppfyllde QC-kriterierna

28 september 2026

Första postat (Faktisk)

1 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • ACR_ROMY_26-09424

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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