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.
Female trial participants aged from 30 to 70 years.
Trial participants who are regular users of anti-aging cosmetic products.
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.
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.
Parallel
Group 1 (Biostimulation + Test product)
Other intervention• 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
Group 2 (Biostimulation + Placebo)
Other intervention• 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
Group 3 (Test product Alone)
Other intervention• 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
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
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
Fine lines score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=none to 9=very visible fine lines
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
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
skin elasticity will be assessed (tactil) by the investigator on a scale from 0=very elastic scale to 9=very loos/not elastic skin
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
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