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

NCT05989165 | Completed Phase 3

• 1 other identifier: 23030294
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (2)

• Density of hair

  Increase density of hair in alopecia androgenetic patient

  12 weeks

• Diameter of hair

  Increase diameter of hair in alopecia androgenetic patient

  12 weeks

Study Arms (2)

Minoxidil 5% solution

EXPERIMENTAL

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

Drug: Minoxidil 5% Topical Solution

Combination therapy of microneedling and minoxidil 5% solution

EXPERIMENTAL

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; Device: microneedling

Interventions

Minoxidil 5% Topical Solution DRUG

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

Combination therapy of microneedling and minoxidil 5% solution; Minoxidil 5% solution

microneedling DEVICE

Patient will be given microneedling treatment every 4 weeks

Combination therapy of microneedling and minoxidil 5% solution

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Indonesian
• Age 18-59 years
• Diagnosis of androgenetic alopecia
• Hamilton-Norwood type III-IV

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangungkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related 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.

  PMID: 23960389 RESULT

• 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.

  PMID: 30886475 RESULT

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Solutions; Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pharmaceutical Preparations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Kara Adistri, MD

  Faculty of medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: June 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 15, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)