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临床试验/CTRI/2019/08/020742
CTRI/2019/08/020742尚未招募未知

An open label clinical study to evaluate efficacy and safety of hair serum in healthy adult male and female volunteers with hairfall.

Sami Labs Limited0 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
未知
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 Male and female subjectsâ?? in general good health.
  • 2 Subjects in the age group 25 to 45 years (both the ages inclusive).
  • 3 Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
  • 4 Hair density of greater than 100 and less than 200 hair follicle per square cm as per Trichoscan measurement
  • 5 Female Subjects falling under Grade 3 - Grade 6 of hair loss severity grade evaluated as per photo numerical10-point scale (Linear scale for assessment purpose-MSCR Scale).
  • 6 Male subjects falling under Grade 3â?? Grade 6 of hair loss severity grade evaluated as per photo numerical10-point scale (Linear scale for assessment purpose - MSCR Scale).
  • 7 Subjects willing to abide by and comply with the study protocol.
  • 8 Subjects who have not participated in a similar investigation in the past three months.
  • 9 Subjects complaining of hair fall and damage.
  • 10 Healthy volunteers with no known allergy as established by medical history.
  • 11 Subjects who do not smoke or drink
  • 12 Subjects who are not crash dieting.
  • 13 Subjects who agree to refrain from using hair dye/hair colour during the study period.
  • 14 Subjects willing to refrain from any type of hair treatment like perming, straightening etc. during the study duration.
  • 15 Subjects who are willing to refrain from any other oil treatment/hair spa and oral medications for hair growth during the study.

排除标准

  • 1 Subjects who have undergone hair growth treatment within 3 months before screening into the study.
  • 2 Subjects having any active scalp diseasesuch as scalp Psoriasiswhichmayinterfere in the study- dermatologistâ??s judgement.
  • 3 Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
  • 4 Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania.
  • 5 Subjects who have had hair transplant.
  • 6 Subjects who take pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia.
  • 7 Subjects with a known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
  • 8 Subjects consuming alcohol and smoking
  • 9 Subjects on oral medications such as vitamin supplements, including multi-vitaminswhich will compromise the study.
  • 10 Subjects who are pregnant or lactating or nursing as established with medical history
  • 11 Subjects under medical treatment for hair problems, prescription drugs such as Minoxidil, Finasteride, or any 5 α-reductase inhibitor or light therapy.
  • 12 Subjects undergoing any chemical hair salon treatment-straightening/perming/colour.
  • 13 Menopausal female subjects as determined by medical history.
  • 14 Subjects with chronic illness which may influence the cutaneous state.
  • 15 Subjects participating in other similar cosmetic or therapeutic trial within last three months.
  • 16 Subjects with medical history of thyroid disorders.
  • 17 Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
  • 18 Subjects who have experienced a known stressful event within the last 6 months such as death in family, miscarriage etc.

研究者

发起方
Sami Labs Limited

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