A prospective, single-arm, single-centre, safety, and efficacy study of anti-acne face wash in healthy adult female subjects having mild to moderate facial acne.

ITC Limited1 个研究点分布在 1 个国家目标入组 37 人开始时间: 2024年1月29日最近更新: 2024年9月17日

试验速览

阶段: 不适用
状态: 已完成
发起方: ITC Limited
入组人数: 37
试验地点: 1
主要终点: 1. To assess the effectiveness of the test treatment in terms of change in skin hydration by using Corneometer CM 825.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A prospective, single-arm, single-centre, safety, and efficacy study of anti-acne face wash in healthy adult female subjectshaving complaints of facial acne.

A total of up to 37 healthy adult non-pregnant/non-lactating females with an age of 18 â€“ 45 years, with equal distribution of mild and moderate acnes will be enrolled to ensure a total of 35 evaluable subjects complete the study.

Subjects will be instructed to visit the facility as per the below visits.

- Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, on site product usage period, Post usage evaluation

- Visit 02 (Day 03): Treatment Phase, Evaluations

- Visit 03 (Day 07): Treatment Phase, Evaluations

- Visit 04 (Day 14): Treatment Phase, Evaluations

- Visit 05 (Day 28 +2 Days): 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 45.00 Year(s)（—）
性别: Female

入选标准

•Age: 18 to 45 years (both inclusive) at the time of consent.
•Sex: Healthy non-pregnant and non-lactating females.
•Females of childbearing potential must have a self-reported negative pregnancy test.
•Subjects are generally in good health.
•Subject with acne of mild to moderate severity as per the IGA scale.
•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 or 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, antihistamines, corticotherapy etc.) that might influence the outcome of the study.
•Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical treatment.
•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 anti-acne products during the study period.
•History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
•Any other condition which could warrant exclusion from the study, as per the dermatologistâ€™s or investigatorâ€™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

1. To assess the effectiveness of the test treatment in terms of change in skin hydration by using Corneometer CM 825.