Comparison of Outcomes Between Topical Minoxidil Versus Oral Minoxidil for the Treatment of Androgenetic Alopecia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-20

Study Completion Date

2026-06-01

Brief Summary

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To compare the outcome of topical minoxidil 5% spray versus oral minoxidil 2.5 mg tablet for the treatment of androgenetic alopecia in males and females. Outcomes include efficacy of the treatment, measured by reduction in hair shedding, improvement in hair density and new hair growth as assessed by physican and patient assessment as well as safety, defined as incidence and severity of adverse events over a treatment period of 6 months

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Detailed Description

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This cohort, adaptive, randomized, double armed group, controlled, investigator-initiated interventional study is designed to demonstrate the superiority of a combination of Topical minoxidil vs oral minoxidil in patients suffering from androgenetic alopecia who consent to randomization following a new diagnosis in Pakistan.

Conditions Androgenetic Alopecia

Intervention/Treatment:

Drug: Oral Minoxidil Drug: Topical Minoxidil

Conditions

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Androgenic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Disease Control

Placebo spray and palcebo tablet

Group Type PLACEBO_COMPARATOR

Placebo Spray

Intervention Type DRUG

placebo spray

Placebo Tablet or Capsule

Intervention Type DRUG

Placebo tablet

Minoxidil Spray Arm

Placebo tablet Mixidil spray

Group Type ACTIVE_COMPARATOR

Minoxidil 5 % Topical Spray

Intervention Type DRUG

Topical spray on hairs

Placebo Tablet or Capsule

Intervention Type DRUG

Placebo tablet

Minoxidil Tablet Arm

Mixidil tablet placebo spray

Group Type ACTIVE_COMPARATOR

minoxidil

Intervention Type DRUG

Oral minoxidil 2.5mg

Placebo Spray

Intervention Type DRUG

placebo spray

Minoxidil Tablet + Spray Arm

Minoxidil spray Minoxidil Tablet

Group Type EXPERIMENTAL

Minoxidil 5 % Topical Spray

Intervention Type DRUG

Topical spray on hairs

minoxidil

Intervention Type DRUG

Oral minoxidil 2.5mg

Interventions

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Minoxidil 5 % Topical Spray

Topical spray on hairs

Intervention Type DRUG

minoxidil

Oral minoxidil 2.5mg

Intervention Type DRUG

Placebo Spray

placebo spray

Intervention Type DRUG

Placebo Tablet or Capsule

Placebo tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with androgenic alopecia Norwood-Hamilton class 2-6 in males and Sinclair class 2-5 in females
* History of androgentic alopecia for at least 1 year
* 18 to 50 years of age
* Willing to provide informed consent
* Willing to not use any other hair loss treatment during the treatment period

Exclusion Criteria

* History of cardiovascular disease
* Use of some other hair restoration therapy in the past 6 months such as minoxidil, finasteride or PRP
* Presence of other causes of alopecia (e.g., alopecia areata, scarring alopecia).
* Pregnant and lactating females
* Previous Hair Transplantation
* Patients with a known hypersensitivity to the study drug or class of study drug
* Patients with co-morbid conditions like chronic liver disease, chronic kidney disease, neurological or psychiatric disorders
* Presence of any other autoimmune disease (especially thyroid disease)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No