CTRI/2024/07/070860尚未招募Unknown
A prospective, interventional, open-label, non-randomized, two-arm, parallel, clinical safety, efficacy and in-use tolerability study of the two test products in healthy adult human subjects having hair fall complaints (alopecia i.e. more than 100 hairs fall per day). - NI
Soulflower – PT INVENT INDIA PVT LTD0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
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: 18 to 55 years (both inclusive) at the time of consent.
- •2) Sex: Healthy 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 more than 100 hair fall per day.
- •6) Subject with self-assessed complaint of thinning of hair.
- •7) 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.
- •8) 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.
- •9) 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.
- •10) Subjects are willing to give written informed consent and are willing to follow the study
- •11) Subjects who commit not to use medicated/ prescription shampoos/hair care products
- •(containing Minoxidil), any other hair growth hair products or hair colour or dye, other than
- •the test products for the entire duration of the study.
- •12) Willing to use test product throughout the study period
排除标准
- •1) History of any dermatological condition of the scalp other than hair loss.
- •2) History of prior use of hair growth treatment within 3 months.
- •3) History of any prior hair growth procedures (e.g., hair transplant or laser).
- •4) 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.
- •5) Subject who perform any salon treatment on hair including haircut during the study period.
- •6) History of alcohol or drug addiction.
- •7) Subjects using other marketed hair fall control and/or hair growth products during the study
- •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
- •12) Any other condition which could warrant exclusion from the study, as per the
- •dermatologist’s/investigator’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.
研究者
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