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

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05989165
• Other study ID #: 23030294
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: September 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 15, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangungkusumo Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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. — View 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 O — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Density of hair	Increase density of hair in alopecia androgenetic patient	12 weeks
Primary	Diameter of hair	Increase diameter of hair in alopecia androgenetic patient	12 weeks