CTRI/2024/12/077682已完成不适用
A prospective, interventional, randomized, double-blind, four-arm, parallel, single-centre, safety, and efficacy study of dark circles corrector products in healthy adult human subjects having under eye dark circles of the vascular origin and pigment origin.
Chemyunion LTDA1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年12月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of the test product in terms of
研究概览
简要总结
A prospective, interventional, randomized, double-blind, four-arm, parallel, single-centre, safety, and efficacy study of dark circles corrector products in healthy adult human subjects having under eye dark circles of the vascular origin and pigment origin
There will be total of 3 visits
Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation
Visit 02 (Day 15): Telephonic follow-up evaluation
Visit 03 (Day 28 +2 Days): Evaluations, End of the study
A total of 88 Subjects will be enrolled to complete 80 Subjects the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 20 to 45 years (both inclusive) at the time of consent.
- •(preferably 30 to 45 years).
- •Sex: Healthy male and non-pregnant/non-lactating females.
- •Females of childbearing potential must have a self-reported negative pregnancy test.
- •Subject are generally in good health.
- •Subject having undereye dark circles of vascular origin and pigment origin based on dermatological assessment.
- •Subject agreed to not to use any other eye care throughout the study period.
- •Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- •If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
- •Females will be considered as non-childbearing potential if they are surgically sterile, have been postmenopausal for at least 1 year or have had a tubal ligation.
- •Subjects are willing to give written informed consent and are willing to come for regular follow up.
- •Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study.
- •Subject who have not participated in a similar investigation in the past three months.
- •Willing to use test product throughout the study period.
排除标准
- •Subjects must not be enrolled in the study if they meet any one of the following criteria: History of any dermatological condition of the skin diseases.
- •Subject with present condition of allergic response to any cosmetic product.
- •Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, antihistamines, corticotherapy etc.) that might influence the outcome of the study.
- •Subjects who have applied topical treatment for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
- •History of alcohol or drug addiction.
- •Subjects using other marketed products during the study period.
- •Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
- •History of chronic illness which may influence the cutaneous state.
- •Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
结局指标
主要结局
To evaluate the effectiveness of the test product in terms of
时间窗: Before product usage on Day 01 and after usage of the test products on Day 28
1.change in L, a, b and ITA by using the skin colorimeter Flex CL 400
时间窗: Before product usage on Day 01 and after usage of the test products on Day 28
2. change in erythema and melanin level by using the Mexameter MX 18.
时间窗: Before product usage on Day 01 and after usage of the test products on Day 28
次要结局
- To assess the effectiveness of the test products in terms of(1. visible change in dark circles through the image analysis)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited
研究点 (1)
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