MedPath

A study to check hair fall benefits

Phase 2
Completed
Registration Number
CTRI/2022/08/044730
Lead Sponsor
Marico Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
70
Inclusion Criteria

1. Male and female subjects in general good health.

2. Subjects in the age group 18-45 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 and female 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 â?? 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, 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Significant improvement in hair growth rate. <br/ ><br>2.Significant improvement in hair thickness. <br/ ><br>3.Significant reduction in hair fall count. <br/ ><br>4.Significant improvement in hair density <br/ ><br>5.Significant improvement in anagen and telogen ratioTimepoint: At Week 2, Week 4, Week 8 & Week 12 in comparison to baseline.
Secondary Outcome Measures
NameTimeMethod
1.Significant improvement in hair thinning. <br/ ><br>2.Significant improvement in density of vellus hair and terminal hair. <br/ ><br>3.overall safety of test product.Timepoint: At Week 2, Week 4, Week 8 & Week 12 in comparison to baseline.
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