A study to evaluate the efficacy of test products in hair fall benefits

Phase 2

Completed

• Registration Number: CTRI/2021/02/030879
• Lead Sponsor: Bajaj Consumer Care Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-06-23
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 91

Inclusion Criteria

1.Female subjectsââ?¬• 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.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).

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 which will compromise the study.

8.Subjects who are pregnant or lactating or nursing as established with medical history.

9.Menopausal female subjects as determined by medical history.

10.Subjects with chronic illness which may influence the cutaneous state.

11.Subjects participating in other similar cosmetic or therapeutic trial within last three months.

12.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

Name	Time	Method
1.Significant improvement in hair growth rate and hair density. <br/ ><br>2.Significant improvement in hair thickness. <br/ ><br>3.Significant reduction in hair fall count. <br/ ><br>4.Significant improvement in hair thinning. <br/ ><br>5.Significant improvement in hair quality.Timepoint: At Day30, Day60, Day90 in comparison to baseline.

Secondary Outcome Measures

Name	Time	Method
To evaluate the product safety by dermatologist assessment.Timepoint: At Day30, Day60, Day90 in comparison to baseline.