drugset / Trial / NCT03852992

Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia

NCT03852992

Phase 2 Withdrawn University of Minnesota
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to evaluate the safety and efficacy of fractionated ablative 10,600nm CO2 laser assisted delivery of 2% minoxidil solution in the treatment of MPHL. In this cohort study, patients will randomly be assigned stand-alone laser treatment, laser assisted drug delivery of minoxidil 2% solution, and laser assisted drug delivery of minoxidil 2% solution plus at home 5% minoxidil treatment. The primary endpoints will be to assess the change from baseline in investigator and subject Hair Growth Assessments (HGA), Hair Growth Index (HGI) and the Hair Growth Satisfaction Scale (HGSS) over 8-12 weeks in each of the three groups. The secondary endpoints will be expert assessment of hair density from baseline and evaluation of safety and adverse events, and pharmacokinetic (PK) data.

Timeline

Start
2022-09-30
Primary completion
2023-07-01
Completion
2023-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Minoxidil Small molecule 5 mg Topical
Subject Minoxidil Small molecule 10 mg Topical
Subject Minoxidil Small molecule 20 mg Topical
Subject Minoxidil Small molecule 40 mg Topical
Subject Minoxidil Small molecule 100 mg Topical