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

University of Indonesia (UI)

Status and phase: Completed; Phase 3

Conditions: Androgenetic Alopecia

Treatments: Device: microneedling; Drug: Minoxidil 5% Topical Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05989165

23030294

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Minoxidil 5% solution

Experimental group

Description:

Patients will receive minoxidil 5%, twice a day, for a total duration of 12 weeks.

Treatment:

Drug: Minoxidil 5% Topical Solution

Combination therapy of microneedling and minoxidil 5% solution

Experimental group

Description:

Patients will receive a combination therapy of microneedling and minoxidil 5%. Minoxidil 5%, will be given twice a day for a total duration of 12 weeks. The microneedling treatment will be given every 4 weeks (week 0, week 4, week 8)for a total duration of 12 weeks.

Treatment:

Drug: Minoxidil 5% Topical Solution

Device: microneedling