CTRI/2024/08/071884尚未招募Unknown
Prospective, interventional, exploratory, four-arm – dose response study, comparative, double-blind, randomized, placebo-control, proof of concept, safety, efficacy and in-use tolerability study of three different dosage formulation of test hair growth products and placebo in patients with mild to moderate Androgenic Alopecia (Grade I to III). - NI
Zywie Ventures Privated 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: 25 to 45 years and above (both inclusive) at the time of consent.
- •2)Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- •3)Females of childbearing potential must have a self-reported negative urine pregnancy.
- •4)Patient is in good general health as determined by the Investigator on the basis of medical history.
- •5)Patients having mild to moderate Androgenic Alopecia (Grade I to III) during clinical study and grade will be evaluated by the dermatologist by using Norwood-Hamilton classification and Ludwig pattern scale for female.
- •6)Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
- •7)Patient 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 patient 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)Patients are willing to give written informed consent and are willing to follow the study procedure.
- •10)Patients who commit not to use any other medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study.
- •11)Willing to consume test products throughout the study period.
- •12)Patient is willing and able to follow and allow study staff to performed study test methods.
- •13)Patient is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •14)Patient must be able to understand and provide written informed consent to participate in the study.
排除标准
- •1)Patient have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
- •2)Patient have history of any dermatological condition of the scalp other than hair loss and dandruff.
- •3)Patient have history of any prior hair growth procedures (e.g. hair transplant or laser).
- •4)Patient who had taken topical treatment of hair loss for at least 4 weeks.
- •5)Patient who had taken any systemic treatment for at least 3 months.
- •6)History of alcohol or drug addiction.
- •7)Patient having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
- •8)Patient who is currently participating in or planning on starting weight loss program that
- •may result in a significant change in overall body weight.
- •9)Pregnant or breast feeding or planning to become pregnant during the study period.
- •10)History of chronic illness which may influence the cutaneous state.
- •11)Patient have participated any clinical research study related to hair care products.
- •12)Patient have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months
研究者
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