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

Phase 3

Completed

• Conditions: Androgenetic Alopecia
• Interventions: Drug: Minoxidil 5% Topical Solution; Device: microneedling

• Registration Number: NCT05989165
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-14
• Status Verified: 2023-09
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-15
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minoxidil 5% solution	Minoxidil 5% Topical Solution	Patients will receive minoxidil 5%, twice a day, for a total duration of 12 weeks.
Combination therapy of microneedling and minoxidil 5% solution	microneedling	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.
Combination therapy of microneedling and minoxidil 5% solution	Minoxidil 5% Topical Solution	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.

Primary Outcome Measures

Name	Time	Method
Density of hair	12 weeks	Increase density of hair in alopecia androgenetic patient
Diameter of hair	12 weeks	Increase diameter of hair in alopecia androgenetic patient

Trial Locations

Locations (1)

Cipto Mangungkusumo Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia