CTRI/2024/07/070558已完成不适用
Open-Label, Interventional, Prospective, Safety, In-Use Tolerability Study of Test Product “No Rays, Thanks Mineral Sunscreen†in healthy adult subjects with dry and sensitive skin.
Kayura Effect LLP1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2024年7月25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
- 27
- 试验地点
- 1
- 主要终点
- To assess the safety of the test product in terms of
研究概览
简要总结
This is open-label, interventional, prospective, safety in-use tolerability study of test product “No Rays, Thanks Mineral Sunscreen†in healthy adult human subjects with dry and sensitive skin. A total of up to 27 subjects will be enrolled to complete 25 subjects the study.
Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, on site product usage, Post usage evaluation at T15 mins.
Visit 02 (Day 15): Evaluations, End of Study.
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
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18 to 55 years (both inclusive) at the time of consent.
- •Sex: Healthy male and non-pregnant/non-lactating females.
- •(Preferably equal ratio of males and females) 3)Females of childbearing potential must have a self-reported negative pregnancy test.
- •Subject are generally in good health.
- •(As per the dermatological evaluation).
- •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 post-menopausal 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.
排除标准
- •History of any dermatological condition of the skin disease.
- •Subject with present condition of allergic response to any cosmetic product.
- •Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
- •History of alcohol or drug addiction.
- •The subject has clinically significant skin disease, which may contraindicate participation, including psoriasis, eczema, skin cancer or other skin pathology.
- •Subjects having skin infections like bacterial, fungal, viral infections.
- •The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading.
- •Be wearing any facial makeup, including false eyelashes, on the day of the study visit.
- •Subjects having hypersensitive skin.
- •Subjects using other marketed sun screen 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 assess the safety of the test product in terms of
时间窗: on Day 1 after usage of test product at T20 mins and Day 15
1.Change in local intolerance assessment for irritation, dryness, Oedema after usage of test product on Day 01 at T15 mins and on Day 15 by the dermatologist.
时间窗: on Day 1 after usage of test product at T20 mins and Day 15
2. Change in local intolerance assessment for irritation, dryness, Oedema after usage of test product on Day 01 at T15 mins and on Day 15 by the Patient Global Assessment Scale.
时间窗: on Day 1 after usage of test product at T20 mins and Day 15
次要结局
- 1.To assess the safety of the test product in terms of change in organoleptic parameters through the subject product perception from baseline before usage of test product on Day 01 and after usage of test product on Day 01 at T20 mins and on Day 15 by using Likert scoring scale.(baseline on Day 1 and after usage of test product on Day 1 at T20 mins and Day 15)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited
研究点 (1)
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