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. - NI

ITC Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

暂无简介。

•1) Age: 18 to 45 years (both inclusive) at the time of consent.
•2) Sex: Healthy non-pregnant and non-lactating females.
•3) Females of childbearing potential must have a self-reported negative pregnancy test.
•4) Subjects are generally in good health.
•5) Subject with acne of mild to moderate severity as per the IGA scale.
•6) 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.
•7) 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.
•8) Subjects are willing to give written informed consent and are willing to come for regular follow up.
•9) Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study.
•10) Subject who have not participated in a similar investigation in the past three months.
•11) Willing to use test product throughout the study period.

•1) History of any dermatological condition of the skin disease.
•2) Subject with present condition of allergic response to any cosmetic product.
•3) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, antihistamines, corticotherapy etc.) that might influence the outcome of the study.
•4) Subject having acne of severe incidence (presence of nodules, cysts or numerous pustules) which requires pharmaceutical treatment.
•5) 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.
•6) History of alcohol or drug addiction.
•7) Subjects using other marketed anti-acne products during the study period.
•8) History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
•9) Any other condition which could warrant exclusion from the study, as per the dermatologist’s or investigator’s discretion.
•10) Pregnant or breastfeeding or planning to become pregnant during the study period.
•11) History of chronic illness which may influence the cutaneous state.
•12) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.

发起方