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

Sponsor

Indonesia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05989165

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Androgenetic Alopecia	Drug: Minoxidil 5% Topical Solution Device: microneedling	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Minoxidil 5% solution Patients will receive minoxidil 5%, twice a day, for a total duration of 12 weeks.	Drug: Minoxidil 5% Topical Solution Patient will be given minoxidil 5% topical solution, twice a day for 12 weeks
Experimental: Combination therapy of microneedling and minoxidil 5% 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.	Drug: Minoxidil 5% Topical Solution Patient will be given minoxidil 5% topical solution, twice a day for 12 weeks Device: microneedling Patient will be given microneedling treatment every 4 weeks

Arm

Intervention/Treatment

Experimental: Minoxidil 5% solution

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

Drug: Minoxidil 5% Topical Solution

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

Experimental: Combination therapy of microneedling and minoxidil 5% 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.

Drug: Minoxidil 5% Topical Solution

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

Device: microneedling

Patient will be given microneedling treatment every 4 weeks

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangungkusumo Hospital	Jakarta	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

Indonesia University

Investigators

Principal Investigator: Kara Adistri, MD, Faculty of medicine, University of Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kara Adistri, MD, Indonesia University

ClinicalTrials.gov Identifier:

NCT05989165

Other Study ID Numbers:

23030294

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Alopecia

Alopecia Areata

Minoxidil

Study Results

No Results Posted as of Aug 14, 2023