MedPath

Hair Growth Clinical study

Phase 2
Completed
Registration Number
CTRI/2022/12/047817
Lead Sponsor
Believe Pte. Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

1.Willing to give informed consent.

2.Healthy male/female volunteers with mild to moderate hair fall aged between 18-55 years.

3.Must be able to adhere to the study visit schedule and other protocol requirements.

4.Willing to complete the questionnaires for the total duration of 45 days.

5.Willing to avoid usage of his/her own hair grooming products.

Exclusion Criteria

1.Inability to provide voluntary consent.

2.Patients with pre existing severe systemic disease necessitating long term medication.

3.Subjects suffering from Trichotillomania a compulsive behaviour that necessitates pulling of hair.

4.Evidence of significant uncontrolled co-morbid disease which in the investigators opinion would jeopardize patient participation.

5.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ necessitating chemotherapy.

6.Use of hair creams, hair shampoo and for one week prior to Baseline.

7.Multivitamins, iron supplements and folate are acceptable, but should be used consistently throughout the study.

8.Subjects who have had a hair head procedure (transplant) within 4 weeks before enrolment or during the study.

9.Subjects who abuse drugs or alcohol (drug screening not required).

10.Local (scalp) and systemic fungal infection

11.History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)

12.Use of any investigational medication within 4 weeks prior to start of study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
â?¢ Visible difference in hair growth from baseline to last visit <br/ ><br>â?¢ % Reduction of hair fall from baseline to last visit. <br/ ><br>Timepoint: Day 0 to Day 45
Secondary Outcome Measures
NameTimeMethod
To evaluate the consumer acceptance as well as their response towards the product through a feedback questionnaire. Timepoint: Day 0 to Day 45
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