CTRI/2025/01/079227已完成不适用
A single centre open label study to evaluate effectiveness and safety of bioactive concentrate VC GROF in improving the signs of ageing in males and females with sensitive skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Clinical scoring of fine lines and wrinkles on forehead crows 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 Population:
Number of Subjects: 35
Demographics: Healthy males and females
Age Range: 35 to 60 years
Completion Goal:
Expected Completers: 30 subjects
Study Visits:
1 Visit 1 D-14
2 Visit 2 D0
3 Visit 3 D28
4 Visit 4 D56
5 Visit 5 D84
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Healthy male and female subjects with sensitive skin aged 35 years to 60 years old both inclusive 2 Fitzpatrick skin phototype III to VI 3 Subjects with minimum grade 2 of fine lines and wrinkles at crows feet skin unevenness density of pigmentary spots cheek sebaceous pores as per Skin aging atlas volume IV Indian skin type by BAZIN & FLAMENT 4 Subjects not using fairness skin spot lightening or antiaging or sunscreen creams lotions 5 Subjects not using any Vitamin C retinol niacinamide glutathione or any other serums creams or supplements which might interfere with study assessments 6 Subjects who have not undergone any aesthetic treatment chemical peels dermabrasion lasers botox fillers etc in the last 6 months and agree not to do in during the study period 7 Subject free of excessive hair acne cuts abrasions fissures wounds lacerations or any other active skin conditions on the face 8 Subject who agrees not to use any other product treatment on their face during the study period 9 Subject who agrees not to carry out bleaching or any other procedures including facial etc on face during the study period 10 Subject to agree to remove all Jewelry onaround face eg necklace earrings if possible nose ring during VISIA CR 5 imaging 11 Female subjects with child-bearing potential willing to undergo Urine Pregnancy Test and to use acceptable methods of contraception 12 Subjects who can read write and understand the informed consent document and are willing to give a written informed consent 13 Subjects ready to follow instructions and study restrictions during the study period.
排除标准
- •1 Subjects having known hypersensitivity to any of the study products or constituents 2 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 3 Participation in any other clinical trial up to 1 month prior to inclusion and during the study 4 Subjects who have any significant skin pathology in the test area 5 Subject who is currently taking any medication including food supplements which the Investigator believes may influence the interpretation of the data 6 Subject having chronic illness or had major surgery in the last year 7 Subjects undergoing any treatment of any skin condition on their face or body 8 Subjects having any allergy or sensitive to bar cleansing products creams or lotions artificial jewellry or anything else.
结局指标
主要结局
Clinical scoring of fine lines and wrinkles on forehead crows 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: Visit 1 Screening visit Day minus 14 | Visit 2 Baseline Day D0 | Visit 3 Evaluation Visit Day 28 | Visit 4 Evaluation Visit Day 56 | Visit 5 End of the study visit Day 84
次要结局
- 1 Evaluation of skin crows feet wrinkles(forehead fine lines wrinkles & cheek sebaceous)
研究者
Dr Sneha Sonker
CIDP Biotech India Pvt. Ltd.
研究点 (1)
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