A Clinical Evaluation of the Safety, In-Use Tolerability, and Efficacy of the Utirixia Lotion and Utirixia Tablet Combination Regimen in Healthy Adults with Dry, Sensitive Skin Prone to Mild to Moderate Pruritus and Urticaria

SAVA Healthcare Limited1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2025年4月30日最近更新: 2025年4月15日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 32
试验地点: 1
主要终点: 1. change in Urticaria

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

This exploratory, prospective, open-label,single-centre, safety, efficacy and in-use tolerability study of the Utixira Lotion+ Utixira Lotion as regimen in healthy adult human subjects with dry orsensitive skin and prone to mild to moderate pruritus or urticaria.

A total of up to 32 healthy male andnon-pregnant | non-lactating female and an age of 18-55 years will be enrolled tocomplete the 30 subjects the study.

- Visit 01 (Day 01): Screening, Enrollment,Baseline Evaluation, On Site Product Usage, Post Usage Evaluation

- Visit 02 (Day 15): Evaluations, Product usage period

- Visit 03 (Day 30): Evaluations, End of the Study

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Not Applicable

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.
•Females of childbearing potential must have a self-reported negative pregnancy test.
•Subject are generally in good health.
•Subject with dry or sensitive skin at a time of screening.
•(Dermatological Assessment) 6)Subjects having pruritus or urticaria at a time of screening.
•Subjects assessment site must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds.
•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 product other than the test product for the entire duration of the study.

排除标准

•History of any dermatological condition of the skin diseases.
•Subject with present condition of allergic response to any cosmetic product.
•Subject having allergic response to the ink.
•Presence of any broken, chapped, cut, irritated, or scraped skin at the application site.
•Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, 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 or cosmeceuticals, herbal treatment.
•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.