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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05989165
Recruitment Status : Completed
First Posted : August 14, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Kara Adistri, Indonesia University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual 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 : June 1, 2023
Actual Primary Completion Date : September 1, 2023
Actual Study Completion Date : September 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Density of hair [ Time Frame: 12 weeks ]
    Increase density of hair in alopecia androgenetic patient

  2. Diameter of hair [ Time Frame: 12 weeks ]
    Increase diameter of hair in alopecia androgenetic patient


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05989165


Locations
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Indonesia
Cipto Mangungkusumo Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Kara Adistri, MD Faculty of medicine, University of Indonesia
More Information
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Publications of Results:

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Responsible Party: Kara Adistri, MD, Indonesia University
ClinicalTrials.gov Identifier: NCT05989165    
Other Study ID Numbers: 23030294
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
 Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents