CTRI/2025/04/085211尚未招募不适用
Evaluation of the in vivo safety and efficacy of cosmetic formulations in conferring tan reduction and skin lightening or brightening benefits on Indian Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ITC LIMITED
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 1)Reduction in skin tan and related hyperpigmentation (Dark spots or blotches or patches, uneven tone).
研究概览
简要总结
Study Summary:
Study Duration: 28 days
Population: 35 Adult Indian Women with skin Tan
Assessments:
(a) Dermatologists assessment
(b) Subjects Self assessment
(c) Instrumental Measurements of skin hydration, TEWL and microtopography
(d) Digital Global Images (For 3-5 subjects)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Healthy subjects 2.Skin that is healthy on the studied anatomic unit 3.Subjects with visible skin Tan on face and dorsal forearm, at least 1 shade darker than the Sun protected upper volar arm as per MASCOT’s Indian skin shade card.
- •4.Subjects with a Chromameter L value in the range of 40 to 60 on cheeks, and L value on volar upper arm of at least 2 units higher than the L value on forehead and dorsal forearm.
- •5.Atleast 20 Subjects with few dark spots (other than melasma or chloasma or rosacea or birth mark or moles or warts or chronic pigmentation) on face.
- •6.Volunteer who exhibit good tolerance to the investigational product with no signs of sensitivity.
- •7.Having Varied skin types 8.Subjects willing to abide by the study protocol, laid restrictions and consenting to visit the site for periodic assessments on the scheduled dates.
排除标准
- •Subjects who have started, changed or stopped a hormonal treatment (hormonal contraception, Hormonal Replacement Therapy, thyroid …) in the past 3 months 2)Subjects who have taken an oral retinoid-based treatment in the past 6 months.
- •Subjects having had a local retinoid-based treatment on the studied areas in the previous month.
- •Subject having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) in the previous week.
- •Subjects having practiced water activities (swimming pool, sauna, hammam) in the previous week 6)Subjets having drunk or eaten caffeine based products (coffee, cola, tea, …), alcohol, highly spiced food or smoked in the two hours preceding the measurements.
- •Subject having practiced sport the day of start of the study.
- •subjects who are either pregnant or nursing.
- •Subjects who have participated in similar kind of investigation.
结局指标
主要结局
1)Reduction in skin tan and related hyperpigmentation (Dark spots or blotches or patches, uneven tone).
时间窗: Baseline, Post 1 product application, Post 24 hours after 1st product application, Day 14, Day 21 and Day 28
2)Improvement in skin Lightening, Brightness or Radiance.
时间窗: Baseline, Post 1 product application, Post 24 hours after 1st product application, Day 14, Day 21 and Day 28
次要结局
- Improvement in skin parameters like Color or complexion, Even tone, Hydration or Moisturization, Clarity, Texture, Softness or Suppleness, Skin brightness or Radiance or Glow, Smoothness compared to baseline as per Dermatologist’s assessment, Subjects’ self-assessment or Instrumental measurements(Baseline, Post 1 product application, Post 24 hours after 1st product application, Day 14, Day 21 and Day 28)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Safety and efficacy check of Product on skinCTRI/2023/02/049829BRIGHT LIFECARE PVT. LTD.36
尚未招募
不适用
The Study to assess safety and effectiveness of product on human volunteersCTRI/2025/04/085889Satiya Nutraceuticals Private Limited72
已完成
不适用
Evaluation of Skin Attributes Following Dietary Supplement ConsumptionSkin ConditionNCT03487965Access Business Group103
尚未招募
不适用
Study to test the safety and effectiveness of test product to provide various skin benefits in participants over 56 days of test product usageCTRI/2025/06/089217Antonio Puig S.A30
已完成
不适用
Safety and Efficacy assessment of Cosmetic Product on skinCTRI/2023/02/049645Ajanta Pharma Ltd36