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Clinical Trials/CTRI/2021/02/031378
CTRI/2021/02/031378
Completed
Phase 3

To evaluate the efficacy of the test product in comparison with a placebo and baseline in improving hair growth rate and hair fall reduction in healthy subjects - None

Marico Limited0 sites161 target enrollmentTBD

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Marico Limited
Enrollment
161
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
December 10, 2021
Last Updated
3 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\.Male subjectsââ?¬• in general good health.
  • 2\.Subjects in the age group 18\-40 years (both the ages inclusive).
  • 3\.Subjects complaining of hair fall and damage.
  • 4\.Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.
  • 5\.Hair density of \>100 and \<200 hair follicle per square cm as per Trichoscan measurement.
  • 6\.Male Subjects falling under Grade 3 \- Grade 6 of hair loss severity grade evaluated as per photo numerical 10\-point scale (Linear scale for assessment purpose\-In Use Scale).
  • 7\.Subjects who are willing to give their hair samples for assessments.

Exclusion Criteria

  • 1\.Subjects who have undergone hair growth treatment within 3 months before screening into the study.
  • 2\.Subjects having any active scalp disease which may interfere in the study ââ?¬â?? dermatologistââ?¬•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, smoking, crash dieting and/ or psychiatric disorder including trichotillomania.
  • 5\.Subjects who have had hair transplant, who have taken pharmaceutical product which cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia, under medical treatment for hair problems.
  • 6\.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
  • 7\.Subjects on oral medications, undergoing any chemical hair salon treatment\-straightening / perming / colour/ henna which will compromise the study.
  • 8\.Subjects with chronic illness which may influence the cutaneous state.
  • 9\.Subjects participating in other similar cosmetic or therapeutic trial within last three months.
  • 10\.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.

Outcomes

Primary Outcomes

Not specified

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