Skin Mitochondrial Protection by R0090948A Active
ConditionSkin Ageing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-45
SponsorL'Oreal
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Skin biopsy
Procedure/Surgery3mm punch skin biopsies on four zones on the back of participant
Treatment groups
13 Participants
are divided into 4 treatment groupsGroup A: Vehicle without UVExperimental treatment 1 intervention
Group B: Vehicle with UVExperimental treatment 1 intervention
Group C: Active without UVExperimental treatment 1 intervention
Group D: Active with UVExperimental treatment 1 intervention
Trial outcomes
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 exposureSecondary outcomes
1
Immunostaining with TOMM20 analyses
Immunostaining (TOMM20) images will be acquired with 3mm punch biopsies
Time frame
24hours after Ultra Violet rays exposure2
Proteomic and Metabolomic analyses
Proteomic and Metabolomic analyses will be done trough tape stripping assessment.
Time frame
24hours after Ultra Violet rays exposure versus baseline3
pigmentation assessment
Skin pigmentation will be assessed through chromametric measurements and clinical scoring.
Time frame
24h and one week after UV exposure versus baselineLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: