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A study to check hair fall benefits

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044730
Enrollment
78
Registered
2022-08-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: PAY-21: Take approximately 3-5ml of the test product. Apply the required quantity while making small partition across the scalp. Start from front and move to the back for uniform applic

Sponsors

Marico Limited
Lead Sponsor

Eligibility

Inclusion criteria

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 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

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.

Design outcomes

Primary

MeasureTime frame
1.Significant improvement in hair growth rate. 2.Significant improvement in hair thickness. 3.Significant reduction in hair fall count. 4.Significant improvement in hair density 5.Significant improvement in anagen and telogen ratioTimepoint: At Week 2, Week 4, Week 8 & Week 12 in comparison to baseline.

Secondary

MeasureTime frame
1.Significant improvement in hair thinning. 2.Significant improvement in density of vellus hair and terminal hair. 3.overall safety of test product.Timepoint: At Week 2, Week 4, Week 8 & Week 12 in comparison to baseline.

Countries

India

Contacts

Public ContactDr Mukesh Ramnane

MS Clinical Research Pvt Ltd

mukesh.ramnane@mscr.in08041125934

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026