A prospective, multi-centre, randomized, double-blind, placebo-controlled, three-arm interventional study to evaluate the safety, efficacy, and in-use tolerability of Hair Growth Oil(s) in subjects with mild to moderate androgenic alopecia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- 1. Hair Growth Rate
研究概览
简要总结
This is a prospective, multi-centre, randomized, double-blind, placebo-controlled, three-arm interventional study designed to evaluate the safety, efficacy, and in-use tolerability of hair growth oil(s) in subjects diagnosed with mild to moderate androgenic alopecia.
A total of 165 healthy male and non-pregnant/non-lactating female subjects (preferably in an equal gender ratio), aged between 25 to 50 years (inclusive), will be enrolled across the three arms (55 subjects per arm). Of these, 132 subjects (44 per arm) are expected to complete the study.
· CASLite Nova or TrichoScanDB 5.0: Measures Hair density, hair thickness, hair growth rate
· TESTRONIX tensile tester: Tensile strength of single Hair strand/subject
· 60 Secs Hair Combing Test – Hair fall from scalp root and hair fall due to breakage
· Hair Pluck Test: Measures Anagen : Telogen Ratio
· Hair Pull Test: Measures Hair Strength
· Dermatologist Assessments:
- Norwood and Hamilton Scoring for males, Ludwig Scoring for females
- General Appearance of Hair à Hair volume, hair plasticity, hair density, hair shininess, hair smoothness, hair oiliness, hair dryness, hair strength.
- General Appearance of Scalp à Itchiness, redness, roughness, scaliness
· Digital Photographs of Head Crown using Nikon Digital D3300 Camera or equivalent
· Image Pro Software – Head crown photography image analysis for number of new hair, baby hair etc.
· Subject perception questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 25 to 50 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.
- •Subject is in good general health as determined by the Investigator on the basis of medical history.
- •Subjects 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 for male and Ludwig pattern scale for female.
- •Subjects who are on contraceptive/hormonal therapy must be 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 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.
- •Subjects 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 use test products throughout the study period.
- •Subject is willing and able to follow and allow study staff to performed study test methods.
- •Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •Subject must be able to understand and provide written informed consent to participate in the study.
排除标准
- •Subject have history of severe hair fall due to any clinically significant self-reported problems like anaemia, thyroid problems.
- •Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
- •Subject have history of any prior hair growth procedures done (e.g. hair transplant or laser).
- •Subject who had taken topical product of hair loss for at least 4 weeks before enrolment.
- •Subject who had taken any systemic product for any illnesses for at least 3 months.
- •History of alcohol or drug addiction.
- •Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
- •Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
- •Pregnant or breast feeding or planning to become pregnant during the study period.
- •History of chronic illness which may influence the cutaneous state.
- •Subject have participated any clinical research study related to hair care products.
- •Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or product of any type of cancer within the last 6 months.
结局指标
主要结局
1. Hair Growth Rate
时间窗: 1. Improvement in hair growth rate evaluated through CASLite Nova or TrichoScanDB 5.0 at four time points — 4 days prior to Day 01, on Day 01, Day 87, and Day 90 (i.e., 3 days post Day 87). | 2. Improvement in hair thickness, density and anagen: telogen ratio evaluated through CASLite Nova or TrichoScanDB 5.0, from baseline (Day 01, prior to product usage) to post-product usage time points on Day 30 (±2 days), Day 60, and Day 90 (±2 days).
To evaluate the efficacy of the test products from baseline in both the affected target area of the scalp and the healthy scalp tattoo-marked area, within each product arm and across product arms.
时间窗: 1. Improvement in hair growth rate evaluated through CASLite Nova or TrichoScanDB 5.0 at four time points — 4 days prior to Day 01, on Day 01, Day 87, and Day 90 (i.e., 3 days post Day 87). | 2. Improvement in hair thickness, density and anagen: telogen ratio evaluated through CASLite Nova or TrichoScanDB 5.0, from baseline (Day 01, prior to product usage) to post-product usage time points on Day 30 (±2 days), Day 60, and Day 90 (±2 days).
2. Hair Density and Hair Thickness
时间窗: 1. Improvement in hair growth rate evaluated through CASLite Nova or TrichoScanDB 5.0 at four time points — 4 days prior to Day 01, on Day 01, Day 87, and Day 90 (i.e., 3 days post Day 87). | 2. Improvement in hair thickness, density and anagen: telogen ratio evaluated through CASLite Nova or TrichoScanDB 5.0, from baseline (Day 01, prior to product usage) to post-product usage time points on Day 30 (±2 days), Day 60, and Day 90 (±2 days).
3. Anagen: Telogen Ratio
时间窗: 1. Improvement in hair growth rate evaluated through CASLite Nova or TrichoScanDB 5.0 at four time points — 4 days prior to Day 01, on Day 01, Day 87, and Day 90 (i.e., 3 days post Day 87). | 2. Improvement in hair thickness, density and anagen: telogen ratio evaluated through CASLite Nova or TrichoScanDB 5.0, from baseline (Day 01, prior to product usage) to post-product usage time points on Day 30 (±2 days), Day 60, and Day 90 (±2 days).
次要结局
- To evaluate the efficacy of the test products by assessing the change in hair fall (from scalp root & due to hair breakage) from baseline before & after usage of the test products arm & across product arms.(Baseline, Day 30, Day 60, Day 90.)
- To assess the efficacy of the test products by evaluating changes in the total hair count on the vertex (head crown) region of the scalp using standardized digital photography captured at a 90° angle & analyzed through image analysis, from baseline to post-product, within each product arm & between product arms.(Baseline, Day 30, Day 60, Day 90)
- To evaluate the efficacy 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 dryness, hair strength from baseline before & after usage of the test products arm & across product arms.(Baseline, Day 30, Day 60, Day 90)
- To evaluate the efficacy of the test products in terms of change in general appearance of scalp i.e. Itchiness, redness, roughness, scaliness & dryness from baseline before & after usage of the test products arm & across product arms.(Baseline, Day 30, Day 60, Day 90)
- To evaluate the efficacy of test products in terms of change in tensile strength of hair from baseline before & after usage of the test products arm & across product arms across product arms.(Baseline, Day 30, Day 60, Day 90)
- To evaluate the efficacy of test products in terms of change in hair strength from baseline before & after usage of the test products arm & across product arms.(Baseline, Day 30, Day 60, Day 90)
- 7.To assess the absorption (for Non-sticky & non-greasy hair) of the test products following application, both within each product arm & comparatively across product arms.(Day 01 T20min)
- To evaluate the efficacy of the test products in terms of product perception questionnaire from both within product arm & between product arms.(Baseline, Day 30, Day 60, Day 90)