Clinical Study of Dabur VatikaNilibringhadi Gold Hair GrowthOil in Comparison to a MarketedComparator and “No Treatmentâ€arm in healthy Human Volunteers

Completed

• Conditions: Healthy Human Complaining of Hair Fall

• Registration Number: CTRI/2020/02/023127
• Lead Sponsor: Dabur India Limited

Brief Summary

Adult subjects of either sex with age between 18-45 years (both inclusive) will be screened for eligibility criteria. On screening visit, before starting any study procedure, written informed consent will be obtained. After that shaving of test area will be performed. The final eligibility will be confirmed with density evaluation two days after shaving (day -14). After confirming the eligibility, the subjects will be asked to use neutral shampoo thrice a week for 14 days. After two weeks of wash out period, at day 1, subject will be randomized to either of three groups i.e. Dabur Vatika Nilibringhadi Gold Hair Growth Oil, Indulekha Bringha Hair Oil and “No treatment.†arm.

All baseline assessment like baseline dermatological assessments and imaging will be performed. This visit will also include shaving of the test area. Post baseline assessments, subjects will be provided with the test product and will be instructed to use the test product for 45 days Further, the subjects will visit the site on day 3 for the phototrichogram assessment. Follow up evaluations will be performed at day 15 & 17, day 30 ad 32 and day 45 & 47. On day 15, 30 and 45, dermatological assessments and imaging will be performed. This visit will also include shaving of the test area. Further, the subjects will visit the site on day 17, 32 and day 47 (two days’ post shaving of the test area) for the phototrichogram assessment. On day 47 (last visit) post completion of the assessments the test product and subject diary will be retrieved and study exit form will be filled up.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-02
• Last Update Posted: 2020-06-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 99

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 & female Subjects falling under Grade 3.
• Grade 6 of hair loss severity grade evaluated as per photo numerical10 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 – dermatologist’s judgment.
• 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.
• phenytoin) and finasteride 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2) Assessment of change in hair growth rate	2, 4 & 6 weeks
1) Assessment of change in hair length	2, 4 & 6 weeks

Secondary Outcome Measures

Name	Time	Method
1) Assessment of change in hair density	2) Assessment of change in anagen and telogen ratio

Trial Locations

Locations (1)

MS Clinical Reserch Pvt Ltd; 🇮🇳 Bangalore, KARNATAKA, India

MS Clinical Reserch Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Sapna Ramnane

Principal investigator

8040917253

sapna.r@mscr.in