Study code: 2324CICL002, Version 1, Dated 01 Aug 2024; A CLINICAL STUDY TO EVALUATE THE ANTI-AGEING EFFICACY OF HUMAN GROWTH FACTORS AND CYTOKINES CONTAINING COSMETIC SKIN SERUM (VC GROF) IN BOTH MALES AND FEMALES WITH SENSITIVE SKIN
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Cipla Ltd
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 1. Clinical scoring of fine lines and wrinkles on forehead, crow’s feet wrinkles, Skin smoothness, skin suppleness, skin evenness, skin firmness, density of pigmentary spots & contrast of isolated pigmentary spot, skin radiance, ptosis and cheek sebaceous pores using Skin aging atlas Volume 4 Asian Skin Type by Dermatologists Investigator.
研究概览
简要总结
Study Overview
-
Study Population:
-
Number of Subjects: 35
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Demographics: Healthy males and females
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Age Range: 35 to 60 years
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Completion Goal:
-
Expected Completers: 30 subjects
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Study Visits:
- Visit 1 (D-14)
- Visit 2 (D0)
- Visit 3 (D28)
- Visit 4 (D56)
- Visit 5 (D84)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female subjects with sensitive skin aged 35 years to 60 years’ old (both inclusive)
- •Fitzpatrick skin phototype III to VI
- •Subjects with minimum grade 2 of fine lines and wrinkles at crow’s feet, skin unevenness, density of pigmentary spots, cheek sebaceous pores as per Skin aging atlas, volume IV Indian skin type, by BAZIN & FLAMENT
- •Subjects not using fairness, skin, or spot lightening or antiaging or sunscreen creams/lotions (preferably about 60% non-users to be included)
- •Subjects not using any Vitamin C, retinol, niacinamide, glutathione, or any other serums/creams or supplements which might interfere with study assessments.
- •Subjects who have not undergone any aesthetic treatment (chemical peels, dermabrasion, lasers, Botox, fillers, etc.,) in the last 6 months and agreeing not to do in during the study period.
- •Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
- •Subject who agrees not to use any other product/treatment on their face during the study period.
- •Subject who agrees not to carry out bleaching or any other procedures including facial etc.
- •on face during the study period.
- •Subject to agree to remove all Jewellery on/around face (e.g., necklace, earrings, if possible, nose ring), during VISIA imaging.
- •Female subjects with child-bearing potential willing to undergo Urine Pregnancy Test and to use acceptable methods of contraception.
- •Subjects who can read, write and understand the informed consent document and willing to give a written informed consent.
- •Subjects ready to follow instructions and study restrictions during the study period.
排除标准
- •Subjects having known hypersensitivity to any of the study products or constituents.
- •Subjects who are pregnant or lactating or who are planning to become pregnant during the study (self-declared by subject on screening visit and test to be done on each evaluation visit except screening visit.
- •Participation in any other clinical trial up to 1 month prior to inclusion and during the study.
- •Subjects who have any significant skin pathology in the test area.
- •Subject who is currently taking any medication including food supplements, which the Investigator believes may influence the interpretation of the data.
- •Subject having chronic illness or had major surgery in the last year.
- •Subjects undergoing any treatment of any skin condition on their face/body.
- •Subjects having any allergy or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else.
结局指标
主要结局
1. Clinical scoring of fine lines and wrinkles on forehead, crow’s feet wrinkles, Skin smoothness, skin suppleness, skin evenness, skin firmness, density of pigmentary spots & contrast of isolated pigmentary spot, skin radiance, ptosis and cheek sebaceous pores using Skin aging atlas Volume 4 Asian Skin Type by Dermatologists Investigator.
时间窗: D-14, D0, D28, D56 & D84
Instrumental Evaluations:
时间窗: D-14, D0, D28, D56 & D84
2. Evaluation of skin crow’s feet wrinkles, forehead fine lines, wrinkles & cheek sebaceous pores using ANTERA 3D Device
时间窗: D-14, D0, D28, D56 & D84
3. Evaluation of skin & spot color using Chromameter CR400
时间窗: D-14, D0, D28, D56 & D84
4. Evaluation of Skin hydration using Corneometer CM 825®/MPA 6
时间窗: D-14, D0, D28, D56 & D84
5. Evaluation of TEWL using Tewameter TM 300/TM Hex
时间窗: D-14, D0, D28, D56 & D84
6. Evaluation of skin firmness using Cutometer MPA 580
时间窗: D-14, D0, D28, D56 & D84
次要结局
- 1. Evaluation of skin crow’s feet wrinkles, forehead fine lines, wrinkles & cheek sebaceous pores using ANTERA 3D Device(2. Evaluation of skin & spot color using Chromameter CR400)