To study the NuHair® Hair Regrowth Products efficacy on Hair Growth in Men with male pattern baldness
- Conditions
- Health Condition 1: null- Androgenic Alopecia
- Registration Number
- CTRI/2014/07/004721
- Lead Sponsor
- Plethico Pharmaceuticals Ltd on behalf of Natrol Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 120
Subjects satisfying all of the following criteria will be considered eligible for enrolment:
1. Males greater that 18 and less than 49 years of age
2. Subjects in good general health with no history of systemic illnesses (eg, cardiac, psychiatric, or scalp disease)
3. Presence of AGA with vertex pattern III to VI on the Modified
Norwood Hamilton Scale (refer to Appendix 18.4)
4. Willingness to maintain the same shampooing habits and products
and comply with product use as specified by the study doctor for the
entire duration of the study
5. Willingness to maintain the same hair style, approximate length
and hair colour throughout the study
6. Subjects willing to provide written informed consent
Subjects satisfying any of the following criteria will not be included in
the study:
1. Subjects who are making use of hair restorers or are on systemic drugs (steroids, cytotoxic agents, vasodilators, antihypertensive
agents, anticonvulsant drugs, adrenergic receptor blockers, diuretics or any of the following specific agents: spironolactone, cimetidine,
diazoxide, cyclosporine, or ketoconazole)
2. Treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment during
6 months prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in the hair count by <br/ ><br>photographic evaluation (from computer-assisted <br/ ><br>scans of macrophotographs of clipped hair in a 1 <br/ ><br>cm2 target evaluation area in the balding vertex <br/ ><br>scalp) at the end of Week 16 in NuHair hair <br/ ><br>regrowth products arm as compared to the <br/ ><br>placebo arm.Timepoint: Day 1 and Day 112
- Secondary Outcome Measures
Name Time Method Assessment of subjectâ??s satisfaction weekly by <br/ ><br>seven point subject self-assessment <br/ ><br>questionnaire.Timepoint: Day 1, Day 28, Day 56 and Day 112;Change in the hair densityTimepoint: Day 1 and Day 112;Change in the hair growthTimepoint: Day 1 and Day 112;Reduction from baseline in serum DHT <br/ ><br>concentration on Week 16Timepoint: Day 1 and Day 112;Safety in terms of adverse eventsTimepoint: Screening Visit, Day 1, Day 28, Day 56 and Day 112;To compare the vellus hair densityTimepoint: Day 1 and Day 112