CTRI/2018/03/012868进行中（未招募）2 期
A Double blind, Placebo Controlled Evaluation of the Effectiveness of an Oral Supplement on Hair Growth and Decreased Hair Shedding in Women with Thinning Hair.
Atlantic Coast Brands0 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
- 2 期
- 状态
- 进行中（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 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 scoring 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 terminal hairs from the target area cut at the base of the scalp for microscopic hair measurements.
- •14 Willingness to have their hair 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 5 α-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 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.
- •15 Individuals who are cognitively impaired and/or who are unable to give informed consent.
- •16 Any other condition which in the Investigatorâ??s opinion may adversely affect the subjectâ??s ability to complete the study or its measures or which may pose significant risk to the subject.
- •17 Subjects with any known allergy or sensitivity to any shampoo or conditioner product.
- •18 Subjects who have experienced a known stressful event within the last 6 months such as Death in family, miscarriage, etc.
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