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This study aims at assessing the efficacy of improving skin aging signs of a serum containing collagen 16 combined with a biostimulation device in healthy female subjects aged between 30 and 70 years over a period of 13 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Biostimulation + Test product) | Experimental |
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| Group 2 (Biostimulation + Placebo) | Placebo Comparator |
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| Group 3 (Test product Alone) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 (Biostimulation + Test product) | Other | • Facial wrinkles, assessed by clinical scoring using the L'Oréal Atlas (volume 1 caucasian type), based on changes from baseline to Week 13. Clinical evaluations, including:
Clinical evaluations, including:
Instrumental measurements, including:
To evaluate trial participant self-perceived efficacy using questionnaires. To assess the local tolerance and safety |
| Measure | Description | Time Frame |
|---|---|---|
| Facial wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=none to 9=very visible wrinkle | wrinkles will be visually assessed on the whole face by the investigator on a scale from 0= no visible wrinkle to 9=very visible wrinkle | at baseline, week 3, week 7 and week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Global wrinkles score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=none to 9=very visible wrinkle | global wrinkles will be visually assessed on the whole face by the investigator on a scale from 0= no visible wrinkle to 9=very visible wrinkle | at baseline, week 3, week 7 and week 13 |
| Fine lines score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=none to 9=very visible fine lines |
| Measure | Description | Time Frame |
|---|---|---|
| Self-perceived efficacy using a specifically developped 20-point questionnaire (agree, somewhat agree, neither agree/neither disagree, somewhat disagree, disagree) | self-perceived efficacy will be assessed using a patient-questionaire assessing i.e. suppleness, softnes, skin texture | at week 3, week 7 and week 13 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire Deloche-Bensmain, PhD | Contact | 0033776112798 | Claire.DELOCHE-BENSMAINE@loreal.com |
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randomized, controlled, parallel-group design with independent assessor blinding
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Masking Description
|
| Group 2 (Biostimulation + Placebo) | Other | • Facial wrinkles, assessed by clinical scoring using the L'Oréal Atlas (volume 1 caucasian type), based on changes from baseline to Week 13. Clinical evaluations, including:
Clinical evaluations, including:
Instrumental measurements, including:
To evaluate trial participant self-perceived efficacy using questionnaires. To assess the local tolerance and safety |
|
| Group 3 (Test product Alone) | Other | • Facial wrinkles, assessed by clinical scoring using the L'Oréal Atlas (volume 1 caucasian type), based on changes from baseline to Week 13. Clinical evaluations, including:
Clinical evaluations, including:
Instrumental measurements, including:
To evaluate trial participant self-perceived efficacy using questionnaires. To assess the local tolerance and safety of the investigational and comparator |
|
fine lines will be visually assessed on yhe whole face by the investigator on a scale from 0= no visible fine lines to 9=very visible fine lines |
| at baseline, week 3, week 7 and week 13 |
| Skin firmness score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very firm skin to 9=very saggy/not firm skin | skin firmness will be assessed (tactile) on a scale from 0=very firm skin to 9= very saggy/not firm skin | at baseline, week 3, week 7 and week 13 |
| Skin elasticity on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very elastic to 9=very loos/not elastic skin | skin elasticity will be assessed (tactil) by the investigator on a scale from 0=very elastic scale to 9=very loos/not elastic skin | at baseline, week 3, week 7 and week 13 |
| Skin tone evenness on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very even skin tone to 9=uneven skin tone | skin tone eveness will be visually assessed by the investigator on scale from 0=very even skin tone to 9= uneven skin tone | at baseline, week 3, week 7 and week 13 |
| Skin radiance on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very radiant complexion to 9=very uneven complexion/dull complexion | skin radiance will be visually assessed by the investigator on a scale from 0=very radiant complexion to 9=very uneven complexion/dull complexion | at baseline, week 3, week 7 and week 13 |
| Skin smoothness on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very smooth skin texture to 9=very rough skin texture | skin smoothness will be visually assessed by the investigator on a scale from 0= very smooth skin texture to 9=very rough skin texture | at baseline, week 3, week 7 and week 13 |
| Ptosis of the lower part of the face on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=no sagging skin to 9=very sagging skin | ptosis (skin sagginess) on the lower face will be visually assessed by the investigator on a scale from 0= no sagging skin (defined contours) to 9=very sagging skin (not defined contours) | at baseline, week 3, week 7 and week 13 |
| Plumpness on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=very plumped skin to 9=not plumped skin | plumpness will be visually assessed by the investigator on the entire face on a scale from 0= very plumped skin to 9=not plumped skin | at baseline, week 3, week 7 and week 13 |
| Dermis density using SIAscope (Spectophotometric intracutaneous analysis; arbitrary units) | Dermis density will be measured using SIAscope (randomized to left or right temple) | at baseline, week 3, week 7 and week 13 |
| Transepidermal waterloss using a tewameter (g/m2/h) | transepidermal water loss will be measured using a tewameter | at baseline, week 3, week 7 and week 13 |
| Skin hydration using a corneometer (arbitary unit) | skin hydration will be measured using a corneometer | at baseline, week 3, week 7 and week 13 |
| Standardised imaging of the face using Visia CR imaging (no unit) | Standardised imaging of the face will be performed using Visia CR | at baseline, week 3, week 7 and week 13 |
| Integrative health questionnaire (23 questions) developped for this study | an integrative health questionnaire will be completed by subjects 7 days before inclusion | Day -7 (7 days before baseline) |
| Safety assessment including local side effects and any adverse event reported by the subject during the course of the study | Evaluation of local tolerance and any adverse event by investigator and trial participants | baseline, week 3, week 7 and week 13 |