Skin Quality, Wrinkle Appearance
Conditions
Keywords
anti-aging, cosmetics, collagen 16, biostimulation, placebo serum
Brief summary
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.
Interventions
OTHERGroup 1 (Biostimulation + Test product)
• 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: * Crow's feet wrinkles (0-6) * Nasolabial folds (0-5) * Underneath eye wrinkles (0-5) * Upper lip wrinkles (0-6) * Wrinkles at the corner of the lips (0-6) Clinical evaluations, including: * Global wrinkles (visual assessment) * Fine lines (visual assessment) * Skin firmness (tactile assessment) * Skin elasticity (tactile assessment) * Skin tone evenness (visual assessment) * Skin radiance (visual assessment) * Skin smoothness (visual assessment) * Ptosis of the lower part of the face (visual assessment) * Plumpness (visual assessment) Instrumental measurements, including: * Dermis density (SIAscope) * Transepidermal water loss (TEWL) (Tewameter) * Skin hydration (Corneometer) * VISIA CR imaging To evaluate trial participant self-perceived efficacy using questionnaires. To assess the local tolerance and safety
OTHERGroup 2 (Biostimulation + Placebo)
• 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: * Crow's feet wrinkles (0-6) * Nasolabial folds (0-5) * Underneath eye wrinkles (0-5) * Upper lip wrinkles (0-6) * Wrinkles at the corner of the lips (0-6) Clinical evaluations, including: * Global wrinkles (visual assessment) * Fine lines (visual assessment) * Skin firmness (tactile assessment) * Skin elasticity (tactile assessment) * Skin tone evenness (visual assessment) * Skin radiance (visual assessment) * Skin smoothness (visual assessment) * Ptosis of the lower part of the face (visual assessment) * Plumpness (visual assessment) Instrumental measurements, including: * Dermis density (SIAscope) * Transepidermal water loss (TEWL) (Tewameter) * Skin hydration (Corneometer) * VISIA CR imaging To evaluate trial participant self-perceived efficacy using questionnaires. To assess the local tolerance and safety
OTHERGroup 3 (Test product Alone)
• 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: * Crow's feet wrinkles (0-6) * Nasolabial folds (0-5) * Underneath eye wrink Clinical evaluations, including: * Global wrinkles (visual assessment) * Fine lines (visual assessment) * Skin firmness (tactile assessment) * Skin elasticity (tactile assessment) * Skin tone evenness (visual assessment) * Skin radiance (visual assessment) * Skin smoothness (visual assessment) * Ptosis of the lower part of the face (visual assessment) * Plumpness (visual assessment) Instrumental measurements, including: * Dermis density (SIAscope) * Transepidermal water loss (TEWL) (Tewameter) * Skin hydration (Corneometer) * VISIA CR imaging To evaluate trial participant self-perceived efficacy using questionnaires. To assess the local tolerance and safety of the investigational and comparator
Sponsors
Vichy Laboratoires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Masking Description
Intervention model description
randomized, controlled, parallel-group design with independent assessor blinding
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Female trial participants aged from 30 to 70 years. * Trial participants who are regular users of anti-aging cosmetic products. * Trial participants presenting with: * Wrinkle visibility score ≥3 and ≤6 on a 10-point visual scale. * Fine lines visibility score ≥3 and ≤6 on a 10-point visual scale. * Crow's feet wrinkle score ≥2 and ≤4 on the L'Oréal Atlas (volume 1 caucasian type). * Skin radiance score ≥3 and ≤6 on a 10-point visual scale. * Plumpness score ≥3 and ≤6 on a 10-point visual scale
Exclusion criteria
* Trial participants who are pregnant, breastfeeding, or planning to become pregnant during the study period. * Trial participants who are currently participating in another facial clinical study or who have participated in such a study within 1 month that may interfere with the study outcomes. * Trial participants presenting with current flaring or severe inflammatory acne or any active dermatological condition that, in the investigator's opinion, could interfere with study assessments. * Trial participants who have undergone ablative laser treatments, microneedling, chemical peels, dermabrasion, non-ablative laser, intense pulsed light (IPL), or injectable procedures within the last 12 months from the day of screening. * Trial participants who have undergone biostimulation procedures in the past 6 to 9 months from the day of screening * Trial participants with a known allergy to any component of the investigational product(s), comparator product(s), or additional products used in the study. * Trial participants presenting with any medical or dermatological condition that, in the investigator's opinion, may compromise trial participant safety or interfere with study conduct or evaluation. * Trial participants who are unable or unwilling to comply with the study requirements and instructions. * Trial participants who are unable to provide written informed consent. * Trial participant with clinically significant history of alcoholism or drug abuse; * Trial participant who are employees of MSCR or Sponsor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facial wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=none to 9=very visible wrinkle | at baseline, week 3, week 7 and week 13 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global wrinkles score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=none to 9=very visible wrinkle | at baseline, week 3, week 7 and week 13 | 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 |
| Fine lines score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=none to 9=very visible fine lines | at baseline, week 3, week 7 and week 13 | 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 |
| Skin firmness score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very firm skin to 9=very saggy/not firm skin | at baseline, week 3, week 7 and week 13 | skin firmness will be assessed (tactile) on a scale from 0=very firm skin to 9= very saggy/not firm skin |
| Skin elasticity on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very elastic to 9=very loos/not elastic skin | at baseline, week 3, week 7 and week 13 | skin elasticity will be assessed (tactil) by the investigator on a scale from 0=very elastic scale to 9=very loos/not elastic skin |
| Skin radiance on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very radiant complexion to 9=very uneven complexion/dull complexion | at baseline, week 3, week 7 and week 13 | skin radiance will be visually assessed by the investigator on a scale from 0=very radiant complexion to 9=very uneven complexion/dull complexion |
| Skin smoothness on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very smooth skin texture to 9=very rough skin texture | at baseline, week 3, week 7 and week 13 | skin smoothness will be visually assessed by the investigator on a scale from 0= very smooth skin texture to 9=very rough skin texture |
| 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 | at baseline, week 3, week 7 and week 13 | 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) |
| Plumpness on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=very plumped skin to 9=not plumped skin | at baseline, week 3, week 7 and week 13 | 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 |
| Dermis density using SIAscope (Spectophotometric intracutaneous analysis; arbitrary units) | at baseline, week 3, week 7 and week 13 | Dermis density will be measured using SIAscope (randomized to left or right temple) |
| Transepidermal waterloss using a tewameter (g/m2/h) | at baseline, week 3, week 7 and week 13 | transepidermal water loss will be measured using a tewameter |
| Skin hydration using a corneometer (arbitary unit) | at baseline, week 3, week 7 and week 13 | skin hydration will be measured using a corneometer |
| Standardised imaging of the face using Visia CR imaging (no unit) | at baseline, week 3, week 7 and week 13 | Standardised imaging of the face will be performed using Visia CR |
| Integrative health questionnaire (23 questions) developped for this study | Day -7 (7 days before baseline) | an integrative health questionnaire will be completed by subjects 7 days before inclusion |
| Skin tone evenness on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=very even skin tone to 9=uneven skin tone | at baseline, week 3, week 7 and week 13 | skin tone eveness will be visually assessed by the investigator on scale from 0=very even skin tone to 9= uneven skin tone |
| Safety assessment including local side effects and any adverse event reported by the subject during the course of the study | baseline, week 3, week 7 and week 13 | Evaluation of local tolerance and any adverse event by investigator and trial participants |
Contacts
CONTACTClaire Deloche-Bensmain, PhD
Outcome results
None listed