Clinical trial

Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men

Name

23030294

Description

The goal of this clinical trial is to compare the effectiveness of combination therapy of microneedling and minoxidil in androgenetic alopecia of Indonesian men. The main questions it aims to answer are: * Is there an increase in hair density with combination therapy of microneedling and minoxidil versus minoxidil monotherapy? * Is there an increase in hair diameter with combination therapy of microneedling and minoxidil versus minoxidil monotherapy? Participants will be divided into 2 groups. The first one will receive minoxidil monotherapy, and the second one will receive a combination therapy of microneedling and minoxidil. Researchers will compare those 2 groups to see if there is a difference of effectiveness based on hair density and diameter.

Trial arms

Trial start

2023-06-01

Estimated PCD

2023-09-01

Trial end

2023-09-15

Status

Completed

Phase

Early phase I

Treatment

Minoxidil 5% Topical Solution

Patient will be given minoxidil 5% topical solution, twice a day for 12 weeks

Arms:

Combination therapy of microneedling and minoxidil 5% solution, Minoxidil 5% solution

microneedling

Patient will be given microneedling treatment every 4 weeks

Arms:

Combination therapy of microneedling and minoxidil 5% solution

Size

Primary endpoint

Density of hair

12 weeks

Diameter of hair

12 weeks

Eligibility criteria

Inclusion Criteria: * Male * Indonesian * Age 18-59 years * Diagnosis of androgenetic alopecia * Hamilton-Norwood type III-IV Exclusion Criteria: * Use of minoxidil or finasteride topical 1 month prior * Use of minoxidil or finasteride oral 1 month prior * Skin infection in the treatment area * Cosmetic procedures for the treatment of alopecia androgenetic such as platelet rich plasma, laser therapy,or microneedling 3 months prior * History of keloid

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}

Updated at

2023-09-28

1 organization

1 product

1 indication

Organization

Indonesia University

Product

Minoxidil

Indication

Androgenetic Alopecia