CTRI/2023/01/048861已完成未知
A Proof-of-Concept, Safety, and Efficacy Study of Anti-Gray Hair Product in Healthy Adult Human Subjects with Partially Gray Hair
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)Age: 20 to 55 years (both inclusive) at the time of consent.
- •2)Sex: Healthy males and non-pregnant/non-lactating females.
- •3)Females of childbearing potential must have a self-reported negative pregnancy test.
- •4)Subject are generally in good health.
- •5)Subject with partially gray hair.
- •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/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)If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
- •9)Subjects are willing to give written informed consent and are willing to follow the study procedure.
- •10)Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil) or any other hair growth, or hair products other than the test product for the entire duration of the study.
- •11)Willing to use test product throughout the study period.
排除标准
- •1)Subjects with any other hair colour except gray.
- •2)History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •3)History of prior use of hair growth treatment within 3 months.
- •4)History of any prior hair growth procedures (e.g., hair transplant or laser).
- •5)Subjects who have applied topical treatment for hair loss 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 hair fall control and/or hair growth products during the study period.
- •8)Subjects who have plans of shaving scalp hair during the study.
- •9)Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •10)History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- •11)Subjects having a history or present condition of an allergic response to any cosmetic products.
- •12)Any other condition which could warrant exclusion from the study, as per the dermatologistâ??s/investigatorâ??s discretion.
- •13)Pregnant or breastfeeding or planning to become pregnant during the study period.
- •14)History of chronic illness which may influence the cutaneous state.
- •15)Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp care products within the last four weeks
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