- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07853027
Skin Mitochondrial Protection by R0090948A Active
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: de Dormael Romain, MsC
- Numéro de téléphone: +33609556837
- E-mail: romain.dedormael@loreal.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Vehicle without UV
Application of vehicle without any UVA1 exposure |
3mm punch skin biopsies on four zones on the back of participant |
|
Expérimental: 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 |
|
Expérimental: 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 |
|
Expérimental: Active with UV
Application of active without UVA1 exposure |
3mm punch skin biopsies on four zones on the back of participant |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Transmission Electron Microscopy analyses
Délai: 24hours after Ultra Violet rays exposure
|
Transmission Electron Microscopy images will be acquired on the 3mm punch biopsies |
24hours after Ultra Violet rays exposure
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Immunostaining with TOMM20 analyses
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- ACR_ROMY_26-09424
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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