Clinical study on Livon Hair Gain Tonic in male baldness.
- Conditions
- Health Condition 1: null- Androgenetic alopecia
- Registration Number
- CTRI/2017/09/009764
- Lead Sponsor
- Marico Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
1).Men having androgenic alopecia with grade 2 or 4 on Norwood Hamilton scale.
2). Men having androgenetic alopecia with baseline A/T ratio in the range of 2 to 4
3). Men who have not undergone any cosmetic hair treatment/s i.e. coloring, bleaching, henna, etc. for the last 2 months.
4).Subjects voluntarily signing an informed consent form and are ready to follow the procedures as per the study protocol.
5).Subjects having primarily healthy scalp without any serious medical condition like psoriasis, dermatitis etc.
6). Subjects ready to exclusively use the study treatment and not to use products with similar benefits during the entire study duration.
1).Subjects having cutaneous illness, localized on tested areas, which could interfere with the clinical evaluation.
2).Subjects having history of allergic dermatitis to cosmetics or hair care products.
3).Subjects having contact allergy or atopic predisposition.
4).Subjects taking treatment for hair fall (local -during last 1month or systemic - during last 3 months).
5).Subjects on any other local (during last 1month) or systemic (during last 3 months) medical treatment that could interfere with hair growth or hair loss e.g. vasodilators, steroids etc.
6).Subjects with history of medical/surgical events that may significantly affect the study outcome e.g. h/o typhoid or jaundice etc.
7).Subjects having history of overtaking medicine which affect androgenetic alopecia.
8).Subjects having hyper sensitivity to any component of the tested product.
9).Subjects exposed to intense sun exposure on a regular basis
10) Subjects having any acute or chronic disease.
11).Subjects who the Investigator considers could be non-compliant with study procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Assessment of Hair re-growth/Hair loss/alopecia progression by Global Photography <br/ ><br>2) Assessment of Hair re-Growth/Hair loss/alopecia using Photo-trichogram <br/ ><br>3) Assessment of Hair loss and alopecia progression by A/T Ratio <br/ ><br>4) Assessment of Hair growth by Anagen Hair <br/ ><br>5) Assessment of Hair density <br/ ><br>6) Assessment of Hair loss by telogen hair count <br/ ><br>7) Assessment of hair loss/ hair fall/ falling hair by telogen hair % <br/ ><br>Timepoint: DAY-1,DAY-3,DAY-43,DAY-45,DAY-88,DAY-90,DAY-178,DAY-180
- Secondary Outcome Measures
Name Time Method 1) Assessment of efficacy of a test product Vs Placebo as per the Dermatologist on CGI-I Scale at the end of the study. <br/ ><br>2) Assessment of efficacy of a test product Vs Placebo as per the subjects at the end of the study. <br/ ><br>3) Assessment of tolerance of a test product on scalp by evaluating occurrence of any ADR like redness, itching, swelling etc. <br/ ><br>4) Assessment of tolerability of a test product by evaluation of occurrence of AE/SAE at all visits from baseline to the end of study <br/ ><br>Timepoint: DAY-1,DAY-3,DAY-43,DAY-45,DAY-88,DAY-90,DAY-178,DAY-180