Health Condition 1: null- Androgenic Alopecia
Conditions
Interventions
Intervention1: NuHair hair regrowth products: NuHair regrowth tablets (twice a day)+
NuHair DHT blocker softgels (Twice a Day) +
NuHair foam (for application on hair twice a day)
Control Intervention1
Sponsors
Plethico Pharmaceuticals Ltd on behalf of Natrol Inc
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the hair count by photographic evaluation (from computer-assisted scans of macrophotographs of clipped hair in a 1 cm2 target evaluation area in the balding vertex scalp) at the end of Week 16 in NuHair hair regrowth products arm as compared to the placebo arm.Timepoint: Day 1 and Day 112 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of subjectâ??s satisfaction weekly by seven point subject self-assessment 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 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 | — |
Countries
India
Contacts
Public ContactDr Neeraj Prasad
Plethico Pharmaceuticals Ltd
Outcome results
None listed