Low Dose Oral Minoxdil in Androgenic Alopecia

NCT ID: NCT07018349

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2025-10-20

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.

Detailed Description

The most prevalent kind of progressive hair loss, androgenetic alopecia (AGA), is becoming more prevalent with growing age. AGA can affect a person's quality of life. For men, it shows up as a noticeable receding frontal hairline, whereas for women, it shows up as overall hair loss with frontal hairline retention. The primary causes of the condition are 5-alpha-reductase and dihydrotestosterone (DHT), which shorten anagen cycles and decrease hair follicles. It is still unclear whether precise processes underlie AGA start and vulnerability. AGA is thought to be a polygenic disorder whose onset and progression are influenced by the interplay of environmental, endocrine, and genetic variables. Several studies have shown that AGA negatively impacts on the quality of life (QoL) and self-esteem of the patients. However, because patients' expectations of treatment outcomes are typically higher than reality, AGA has continued to be a therapeutic problem for dermatologists.

FDA-approved treatment managements for AGA at present include oral finasteride, topical minoxidil 2%-5%, and low-level light therapy. The most often recommended drug among them is topical minoxidil solution. The selection of treatments for androgenetic alopecia therapy is still difficult as it requires moral, evidence-based judgment and takes into account the demands, compliance, financial constraints, degree of hair loss, and cosmetic preferences of each patient. Despite the fact that there are several medication, surgery, light-based, and nutraceutical treatment options available to stop or reverse the progression of AGA, selecting the best treatments for this chronic condition can be challenging. This study aims to determine which dose offers the best balance of efficacy and safety for AGA patients.

This study will be an RCT study. All patients will be adequately informed about the treatment regimen, follow-ups, and likely adverse effects before the start of the study. A written consent form will be obtained from each patient.

The study's eligibility for participation will be assessed for patients with AGA with the severity ranging from mild to moderate AGA. All AGA patients will get a trichoscopy and a complete scalp examination on their first appointment in order to rule out other hair-loss conditions, such as other types of alopecia like scarring or inflammatory and alopecia areata. Each patient's AGA stage will then be ascertained using the Savin scale for female patients and the "Norwood Hamilton scale" for male patients. Individuals who meet the clinical and trichoscopic criteria for mild to moderate AGA will be assessed for trial eligibility. Before beginning therapy, testing for hematological disorders, liver, kidney, thyroid, electrolytes, and pregnancy will be conducted. At 3-month follow-up appointment, measurements of body weight and blood pressure will also be taken.

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.

Conditions

Androgenetic Alopecia (AGA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Minoxidil 2.5% mg

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

Group Type: EXPERIMENTAL

2.5% Oral minoxidil

Intervention Type: 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 1% mg

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

Group Type: EXPERIMENTAL

1% Oral Minoxidil

Intervention Type: DRUG

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

Interventions

2.5% Oral minoxidil

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.

Intervention Type: DRUG

1% Oral Minoxidil

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hala Batool

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jinnah PMC

Karachi, Sindh, Pakistan

Countries

Pakistan

Central Contacts

Hala Batool, MBBS, FCPS Trainee

Role: CONTACT

soomro7770@gmail.com

+92- 334-3414942

Other Identifiers

No.F.2-81/2025-GENL/258/JPMC

Identifier Type: -

Identifier Source: org_study_id