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

Primary Purpose

Androgenetic Alopecia

Status

Completed

Phase

Phase 3

Locations

Indonesia

Study Type

Interventional

Intervention

Minoxidil 5% Topical Solution

microneedling

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - 59 Years (Adult)MaleDoes not accept 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

Sites / Locations

Cipto Mangungkusumo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Minoxidil 5% solution

Combination therapy of microneedling and minoxidil 5% solution

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Density of hair

Increase density of hair in alopecia androgenetic patient

Diameter of hair

Increase diameter of hair in alopecia androgenetic patient

Secondary Outcome Measures

Full Information

NCT ID

NCT05989165

First Posted

August 3, 2023

Last Updated

September 27, 2023

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT05989165

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2023 (Actual)

Primary Completion Date

September 1, 2023 (Actual)

Study Completion Date

September 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

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.

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Androgenetic Alopecia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Minoxidil 5% solution

Arm Type

Experimental

Arm Description

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

Arm Title

Combination therapy of microneedling and minoxidil 5% solution

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Minoxidil 5% Topical Solution

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

microneedling

Intervention Description

Patient will be given microneedling treatment every 4 weeks

Primary Outcome Measure Information:

Title

Density of hair

Description

Increase density of hair in alopecia androgenetic patient

Time Frame

12 weeks

Title

Diameter of hair

Description

Increase diameter of hair in alopecia androgenetic patient

Time Frame

12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kara Adistri, MD

Organizational Affiliation

Faculty of medicine, University of Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cipto Mangungkusumo Hospital

City

Jakarta

State/Province

DKI Jakarta

ZIP/Postal Code

10430

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23960389

Citation

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.

Results Reference

result

PubMed Identifier

30886475

Citation

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.

Results Reference

result

Learn more about this trial

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

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