CTRI/2024/08/071884已完成不适用
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).
Zywie Ventures Privated Ltd1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年8月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1.To assess the effectiveness of the test products in terms of change in hair thickness, and hair density by using CASLite Nova.
研究概览
简要总结
This is a 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).
A total of up to 72 patients (18 patients/arm) preferably equal number of male and female will be enrolled to ensure a total of 60 patients (15 patients/ arm) to complete the study.
There will be total of 8 visits during the study. The duration of the study will be 180 days (6 months) from the enrolment.
visit 1: screening
visit 2: enrolment and baseline evaluation
visit 3: Product phase and Evaluation Visit
visit 4:Tattoo creation and Evaluations
visit 5:Evaluations
visit 6:Evaluations
visit 7:Tattoo creation and Evaluations
visit 8:Evaluations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 25 to 45 years and above (both inclusive) at the time of consent.
- •Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- •Females of childbearing potential must have a self-reported negative urine pregnancy.
- •Patient is in good general health as determined by the Investigator on the basis of medical history.
- •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.
- •Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
- •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.
- •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.
- •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.
- •Willing to consume test products throughout the study period.
- •Patient is willing and able to follow and allow study staff to performed study test methods.
- •Patient is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •Patient must be able to understand and provide written informed consent to participate in the study.
排除标准
- •Patient have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
- •Patient have history of any dermatological condition of the scalp other than hair loss and dandruff.
- •Patient have history of any prior hair growth procedures (e.g. hair transplant or laser).
- •Patient who had taken topical treatment of hair loss for at least 4 weeks.
- •Patient who had taken any systemic treatment for at least 3 months.
- •History of alcohol or drug addiction.
- •Patient having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
- •Patient who is currently participating in or planning on starting weight loss program that may result in a significant change in overall body weight.
- •Pregnant or breast feeding or planning to become pregnant during the study period.
- •History of chronic illness which may influence the cutaneous state.
- •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.
结局指标
主要结局
1.To assess the effectiveness of the test products in terms of change in hair thickness, and hair density by using CASLite Nova.
时间窗: 1. Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135, and on Day 180. | 2.04 days before Day 01, Day 01, Day 87, Day 90 and on Day 177, Day 180.
2.To assess the effectiveness of the test products in terms of change in hair growth rate by using CASLite Nova
时间窗: 1. Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135, and on Day 180. | 2.04 days before Day 01, Day 01, Day 87, Day 90 and on Day 177, Day 180.
次要结局
- 1. To assess the effectiveness of the test products in terms of change in keratin measurement from hair by using CASLite Nova(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 , and on Day 180)
- 2. To assess the effectiveness of the test products in terms of change in hair length (AG affected area and standard area) by using CASLite Nova and calibrated ruler respectively(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 , and on Day 180)
- 3. To assess the effectiveness of the test products in terms of change in A:T ratio by hair pluck test(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 90 and on Day 180.)
- 4. To assess the effectiveness of the test products in terms of change hair fall from root test by 60 seconds hair combing test(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 , and on Day 180)
- 5. To assess the effectiveness of the test products in terms of change in number of new hairs by using CASLite Nova(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 , and on Day 180)
- 6. To assess the effectiveness of the test products in terms of change in hair regrowth by using CASLite Nova(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 , and on Day 180)
- 7. To assess the effectiveness of the test products in terms of change in hair root strength by dermatological assessment(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 , and on Day 180)
- 8. To assess the effectiveness of the test products in terms of change in general appearance of hair i.e. hair volume, hair plasticity, hair density, hair shininess, hair smoothness, hair oiliness, hair dryness and hair strength(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 , and on Day 180)
- 9. To assess the effectiveness of the test products in terms of change in general appearance of scalp i.e. Itchiness, redness, roughness, and scaliness(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 , and on Day 180)
- 10. To evaluate the effectiveness of the test products in terms of change in products perception questionnaire(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 , and on Day 180)
- 11. To assess the effectiveness of the test products in terms of change in tensile strength of hairs(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 180)
- 12.To evaluate the effect of test products in terms of change in nail brittleness(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 180)
- 13. To evaluate the effect of test products in terms of change in haematology i.e. CBC- haemoglobin, hematocrit, RBC, MCH, MCV, MCHC, WBC(Baseline before usage of test products on Day 01 and after usage of test products on Day 180.)
- 14. To evaluate the effect of test products in terms of change in Biochemistry- SGOT, SGPT, serum creatinine, blood urea nitrogen (BUN), random blood sugar (RBS), PPBS, TC, TG, HDL, LDL, uric acid, VLDL(Baseline before usage of test products on Day 01 and after usage of test products on Day 180.)
- 15. To evaluate the effect of test products in terms of change in testosterone, free testosterone, dihydrotestosterone(Baseline before usage of test products on Day 01 and after usage of test products on Day 180.)
- 16.To evaluate the effect of test products in terms of change in CRP, random cortisol(Baseline before usage of test products on Day 01 and after usage of test products on Day 180.)
- 17.To evaluate the effect of test products in terms of change in ferritin(Baseline before usage of test products on Day 01 and after usage of test products on Day 180)
- 18.To evaluate the effect of test products in terms of change in urinalysis(Baseline before usage of test products on Day 01 and after usage of test products on Day 180 .)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited
研究点 (1)
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