A Double-blind, Randomized, Controlled Evaluation of the Effectiveness of an Oral Supplement on Hair Growth and Decreased Hair Shedding in Women with Thinning Hair.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1 Change in Visible Hair density by Macro photography.
研究概览
简要总结
A prospective, randomized, double blind, active controlled study in 40 adult female volunteers in the age group of greater than equal to 20 and less than equal to 55 years with self perceived mild to moderate hair thinning will be conducted to evaluate the effectiveness of SBA-1001 Oral Supplement. The individual subject participation will be for 120 days, may be extended to 180 days as per Sponsor discretion based on interim results. The primary endpoints for the study are changes in the number of terminal hair by macro photography. trichoscan analysis and modified hair wash test. The secondary endpoints are improvement in hair growth using 7-point scale, Savins scale, self analysis of hair growth, subject satisfaction of hair condition questionnaire. Statistical analysis will be performed as listed in the protocol.
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
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Healthy females, minimum age greater than equal to 20 years and maximum age less than equal to 55 years of age.
- •2 Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- •3 Self-perceived mild to moderate hair thinning as assessed through a questionnaire associated with diet, stress, or hormonal influences.
- •4 Willing to allow hair shampooing as per study procedure.
- •5 Willingness to maintain cut of hair over the duration of the study, and to maintain all other general hair regimens.
- •6 Compliance to all study procedures including those required for Trichoscan measurements.
- •7 Has given voluntary, written, informed consent to participate in the study.
- •8 Agree to not substantially change diet, medications or exercise routine for the duration of the study.
- •9 Willing to add the provided oral supplement to their daily routine.
- •10 Willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, general physical findings and a scalp exam.
- •11 Females with Fitzpatrick I-IV photo skin types and as per Savin hair loss classification.
- •12 Willingness to have digital photography of the target area of scalp for hair counts.
- •13 Willingness to have ten (10) terminal hairs from the target area cut at the base of the scalp for microscopic hair measurements.
- •14 Willingness to have their hair washed (shampooed) with Keranique Scalp Replenishing Shampoo – Damage Control over a sink containing a gauze for hair shedding counts.
- •15 Willingness of subjects who have color-treated hair can have the color treatment performed, but with no interference in the study procedures such as Modified hair wash test.
排除标准
- •1 Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
- •2 Women who have begun hormonal birth control or hormone replacement within 6 months of randomization.
- •3 Subjects taking vitamin supplements, including multi-vitamins, within 2 weeks of randomization.
- •4 Subjects having undergone a form of treatment for thinning hair, including prescription drugs such as Minoxidil, Finasteride, or any 5α-reductase inhibitor or light therapy within 6 months of randomization.
- •5 Medical history of diagnosed hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia, and telogen effluvium trichotillomania (compulsive hair pulling) as determined on initial study assessment by the Investigator.
- •6 Subjects currently using hair extensions.
- •7 Subjects with psoriasis or any active dermatological condition of the scalp at randomization that in the opinion of the qualified investigator would interfere with the clinical evaluations.
- •8 Subjects using or having used, within the last 6 months, any prescription medication known to affect the hair growth cycle.
- •9 Medical history of thyroid disorders.
- •10 Unstable medical conditions as determined by qualified investigator, or any self-reported uncontrolled disease, such as diabetes, hypertension.
- •Medical conditions that are under control with or without treatment will be considered on an individual basis by investigators.
- •11 Females with self-reported active hepatitis, immune deficiency, HIV or Autoimmune disease.
- •12 Clinically significant abnormal laboratory results at screening.
- •13 Participation in a clinical research trial within 30 days prior to randomization.
- •14 Allergy or sensitivity to study supplement ingredients.
- •16 Any other condition which in the Investigator’s opinion may adversely affect the subject’s ability to complete the study or its measures or which may pose significant risk to the subject.
- •18 Subjects who have experienced a known stressful event within the last 6 months such as Death in family, miscarriage, etc.
结局指标
主要结局
1 Change in Visible Hair density by Macro photography.
时间窗: 1 Macro photography(Baseline,Day30,Day60,Day90,Day120 and Day180). | 2 Trichoscan HD analysis(Baseline,Day120 and Day180). | 3 Modified hair wash test(Baseline,Day10,Day20,Day30,Day40,Day50,Day60,Day70,Day80,Day90,Day100,Day110,Day120,Day130,Day140,Day150,Day160,Day170 and Day180).
2 Change in Hair density, hair diameter, hair growth rate and anagen/telogen ratio by Trichoscan HD analysis.
时间窗: 1 Macro photography(Baseline,Day30,Day60,Day90,Day120 and Day180). | 2 Trichoscan HD analysis(Baseline,Day120 and Day180). | 3 Modified hair wash test(Baseline,Day10,Day20,Day30,Day40,Day50,Day60,Day70,Day80,Day90,Day100,Day110,Day120,Day130,Day140,Day150,Day160,Day170 and Day180).
3 Change in number of hair shed by Modified hair wash test.
时间窗: 1 Macro photography(Baseline,Day30,Day60,Day90,Day120 and Day180). | 2 Trichoscan HD analysis(Baseline,Day120 and Day180). | 3 Modified hair wash test(Baseline,Day10,Day20,Day30,Day40,Day50,Day60,Day70,Day80,Day90,Day100,Day110,Day120,Day130,Day140,Day150,Day160,Day170 and Day180).
次要结局
- 1 Global assessment of improvement in hair growth using 7-point scale.(2 Savin Scale by direct visual examination.)