MedTrace Logo

Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia

NCT03852992 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-09-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Post-Laser Minoxidil 2%

2ml of 20mg/ml sterile solution, applied post-laser procedure

DRUG

At-Home Minoxidil 5%

2ml of 50mg/ml foam q24 h for duration of study

DEVICE

Laser

Fractional ablative, deep mode, 5% fractional coverage

DRUG

Post-laser 5mg minoxidil

0.25ml of 20mg/ml sterile solution, applied post-laser procedure

DRUG

Post-laser 10mg minoxidil

0.5ml of 20mg/ml sterile solution, applied post-laser procedure

DRUG

Post-laser 20mg minoxidil

1ml of 20mg/ml sterile solution, applied post-laser procedure

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-07-01
Completion
2023-07-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03852992 on ClinicalTrials.gov