Low Dose Oral Minoxdil in Androgenic Alopecia

NCT07018349 | Not Yet Recruiting

• 1 other identifier: No.F.2-81/2025-GENL/258/JPMC
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

In order to successfully treat androgenetic alopecia (AGA), this study compares the efficacy of low-dose oral minoxidil dosages of 0.25 mg and 1 mg. It addresses a critical gap in current research, as few studies have examined the relationship between low dosage and outcomes like hair diameter, density, patient satisfaction, and adverse effects, including hypertrichosis. Previous research suggests that low dose of oral minoxidil is a safe and well-tolerated option for hair loss, but the optimal dose for maximizing benefits while minimizing side effects remains unclear. This study aims to determine which dose offers the best balance of efficacy and safety for AGA patients.

Conditions

Androgenetic Alopecia (AGA)

Keywords

androgenetic alopecia (AGA); Minoxdil; Low oral doses

Outcome Measures

Primary Outcomes (2)

• Hair count and Thickness

  Three distinct areas of the scalp will be marked with jet black Micropigment to guarantee precise measurements. These sites, which will be called the vertex points, mid-frontal, and frontal, respectively, were situated 12, 16, and 24 cm from the glabella. Following the application of just one drop of pigment to the selected area, the ink will be tattooed onto the skin using an insulin needle. The tattooed regions were photographed from a distance using a dermoscopic gadget (FotoFinder System Gmbh) that was linked to a camera (Canon EOS M100 DSLR) and a mobile phone. A trichology-trained technician who was blind to the process manually counted the number of hairs in a 1 cm 2 area surrounding each marked spot. Five randomly chosen hairs near the tattooed region will have their thicknesses measured with 3D-Slicer software, and the results will be averaged.

  3 months

• Photographic assessment

  A standardized global pretreatment picture of the mid-anterior scalp will be taken using a digital camera in a fixed position, with the use of stereotactic positioning equipment, illumination, and styling. Additionally, close-up pictures of the tattooed areas will be taken at 12cm, 16cm, and 24cm from the glabella. A standardized seven-point rating system was used by two blind investigators to evaluate the photos separately.

  3 month

Secondary Outcomes (1)

• Patient satisfaction

  3 month

Study Arms (2)

Oral Minoxidil 2.5% mg

EXPERIMENTAL

Group-A: 2.5% mg of minoxidil once daily, orally.

Drug: 2.5% Oral minoxidil

Oral Minoxidil 1% mg

EXPERIMENTAL

Group-B: 1% mg of minoxidil once daily orally.

Drug: 1% Oral Minoxidil

Interventions

2.5% Oral minoxidil DRUG

AGA patients will be randomly allocated in both groups using the envelopes method to reduce the biasness. For 3-months, patients in Group-A will get 2.5mg of minoxidil once daily, while those in Group-B will receive 1mg of minoxidil once daily orally. After starting therapy, patients will be asked to come back for evaluations 3 months later. Safety, satisfaction, and the effects of the treatment will be reported. Final outcomes will be evaluated at 3 months post treatment.

Oral Minoxidil 2.5% mg

1% Oral Minoxidil DRUG

Group-B will receive 1mg of minoxidil once daily orally

Oral Minoxidil 1% mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients have a clinical and trichoscopic diagnosis of mild to severe AGA

You may not qualify if:

• Patients who, within three months before the trial, had undergone systemic or topical therapies for AGA
• People who suffer from additional hair loss conditions such hyperandrogenism, scarring or inflammatory alopecia, or any hormonal disorders.
• Sensitivity to minoxidil
• Patients with history of severe systemic diseases (heart, renal, or hepatic), a history of hypertension or hypotension, pregnant and breast-feeding women will also be excluded.
• Patient who will not be willing to provide written informed consents.

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

Jinnah PMC

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

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

Central Study Contacts

Hala Batool, MBBS, FCPS Trainee

CONTACT

+92- 334-3414942; soomro7770@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: AGA patients will be randomly allocated in both groups using the envelopes method to reduce the biasness. For 3-months, patients in Group-A will get 2.5mg of minoxidil once daily, while those in Group-B will receive 1mg of minoxidil once daily orally.

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 12, 2025
• Study Start: June 15, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 20, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)