A study to check hair growth benefits

Phase 2

Registration Number: CTRI/2024/03/063657

Lead Sponsor: Marico Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male and female subjects in general good health.

2.Subjects in the age group 18-50 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 greater than 100 and less than 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 MSCR photo numerical 10-point scale (Linear scale for assessment purpose-In Use Scale).

Exclusion Criteria

1 Subjects who have undergone any kind of hair growth treatment in the last 3 months

2 Subjects having any active but controllable scalp disease which may interfere in the study assessments

3 Subjects who have taken chemotherapy for cancer in the 6 months prior to the studys start

4 Subjects who have history of crash dieting and or psychiatric disorder including trichotillomania

5 Subjects who have undergone hair transplant

6 A known history or present condition of allergic response or hypersensitivity to any topical or oral cosmetic pharmaceutical or nutraceutical product

7 Subjects on oral medications like topical or systemic corticosteroids undergoing any chemical hair salon treatment which will compromise the study

8 Subjects with chronic illness which may influence the cutaneous state

9 Subjects who are pregnant or nursing Self declared

10 Subjects with any history or present of underlying uncontrolled medical illness or any other serious medical illness

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Reduction in hair fall by comb test <br/ ><br>•Improvement in hair growth rate, hair thickness, hair density by TrichoScan and dermatological assessments <br/ ><br>•Change in anagen and telogen ratio by TrichoScanTimepoint: at Baseline, Week 2, Week 4, Week 8, Week 12

Secondary Outcome Measures

Name	Time	Method
•Change in hair thinning by dermatologists <br/ ><br>•Overall safety of test product <br/ ><br>•Change in density of vellus hair & terminal hairTimepoint: at Baseline, Week 2, Week 4, Week 8, Week 12