NCT07446361尚未招募不适用
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
Vichy Laboratoires0 个研究点目标入组 180 人开始时间: 2026年3月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- Facial wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=none to 9=very visible wrinkle
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking Description
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1 (Biostimulation + Test product)
Experimental
- application of collagen 16 serum (morning and evening)
- Capital Soleil Family Milk SPF 30 (morning)
- La Roche-Posay Hydraphase Light (evening)
- Biostimulation injection at Visit 2
干预措施: Group 1 (Biostimulation + Test product) (Other)
Group 2 (Biostimulation + Placebo)
Placebo Comparator
干预措施: Group 2 (Biostimulation + Placebo) (Other)
Group 3 (Test product Alone)
Active Comparator
干预措施: Group 3 (Test product Alone) (Other)
结局指标
主要结局
Facial wrinkle score on the L'Oreal Skin Atlas (Caucasian type) scale ranging from 0=none to 9=very visible wrinkle
时间窗: 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
次要结局
- 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)
- 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)
- 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 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 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 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 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)
- 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)
- 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)
- Dermis density using SIAscope (Spectophotometric intracutaneous analysis; arbitrary units)(at baseline, week 3, week 7 and week 13)
- Transepidermal waterloss using a tewameter (g/m2/h)(at baseline, week 3, week 7 and week 13)
- Skin hydration using a corneometer (arbitary unit)(at baseline, week 3, week 7 and week 13)
- Standardised imaging of the face using Visia CR imaging (no unit)(at baseline, week 3, week 7 and week 13)
- Integrative health questionnaire (23 questions) developped for this study(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(baseline, week 3, week 7 and week 13)
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