A Study to Evaluate the Efficacy of Collagen 16 Serum Alone, Against and as an Adjunct to Radiesse® Biostimulation Procedure in Female Trial Participants With Aged Skin

Официальное название

A Randomized Clinical Study to Evaluate the Efficacy of Collagen 16 Serum Alone, Against and as an Adjunct to Radiesse® Biostimulation Procedure in Female Trial Participants With Aged Skin

Обзор

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.

Вмешательства

• Другое Group 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 (tacti
• Другое Group 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 (tacti
• Другое Group 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

Первичные конечные точки

• Facial wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=none to 9=very visible wrinkle [Срок оценки: at baseline, week 3, week 7 and week 13]

Вторичные конечные точки (12)

• Global wrinkles score on the L'Oreal Skin Atlas (Caucasian type) ranging from 0=none to 9=very visible wrinkle [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: at baseline, week 3, week 7 and week 13]
• Dermis density using SIAscope (Spectophotometric intracutaneous analysis; arbitrary units) [Срок оценки: at baseline, week 3, week 7 and week 13]
• Transepidermal waterloss using a tewameter (g/m2/h) [Срок оценки: at baseline, week 3, week 7 and week 13]
• Skin hydration using a corneometer (arbitary unit) [Срок оценки: at baseline, week 3, week 7 and week 13]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07446361 · VCY25-010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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