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

NCT ID: NCT05989165

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-09-15

Brief Summary

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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

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Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Minoxidil 5% solution

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

Group Type EXPERIMENTAL

Minoxidil 5% Topical Solution

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Minoxidil 5% Topical Solution

Intervention Type DRUG

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

microneedling

Intervention Type DEVICE

Patient will be given microneedling treatment every 4 weeks

Interventions

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Minoxidil 5% Topical Solution

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

Intervention Type DRUG

microneedling

Patient will be given microneedling treatment every 4 weeks

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Kara Adistri

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kara Adistri, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine, University of Indonesia

Locations

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Cipto Mangungkusumo Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

References

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Dhurat R, Sukesh M, Avhad G, Dandale A, Pal A, Pund P. A randomized evaluator blinded study of effect of microneedling in androgenetic alopecia: a pilot study. Int J Trichology. 2013 Jan;5(1):6-11. doi: 10.4103/0974-7753.114700.

Reference Type RESULT
PMID: 23960389 (View on PubMed)

Kumar MK, Inamadar AC, Palit A. A Randomized Controlled, Single-Observer Blinded Study to Determine the Efficacy of Topical Minoxidil plus Microneedling versus Topical Minoxidil Alone in the Treatment of Androgenetic Alopecia. J Cutan Aesthet Surg. 2018 Oct-Dec;11(4):211-216. doi: 10.4103/JCAS.JCAS_130_17.

Reference Type RESULT
PMID: 30886475 (View on PubMed)

Other Identifiers

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23030294

Identifier Type: -

Identifier Source: org_study_id

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