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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Androgenic Alopecia
• Intervention / Treatment: Drug: Placebo Spray; Drug: Placebo Tablet or Capsule; Drug: Minoxidil 5 % Topical Spray; Drug: minoxidil

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Disease Control; Placebo spray and palcebo tablet	Drug: Placebo Spray; placebo spray; Drug: Placebo Tablet or Capsule; Placebo tablet
Active Comparator: Minoxidil Spray Arm; Placebo tablet Mixidil spray	Drug: Placebo Tablet or Capsule; Placebo tablet; Drug: Minoxidil 5 % Topical Spray; Topical spray on hairs
Active Comparator: Minoxidil Tablet Arm; Mixidil tablet placebo spray	Drug: Placebo Spray; placebo spray; Drug: minoxidil; Oral minoxidil 2.5mg
Experimental: Minoxidil Tablet + Spray Arm; Minoxidil spray Minoxidil Tablet	Drug: Minoxidil 5 % Topical Spray; Topical spray on hairs; Drug: minoxidil; Oral minoxidil 2.5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of drug	The effectiveness of the treatment in terms of reduction in hair shedding, improvement in hair density, and new hair growth will be measured by a standardised seven point scale for physician photographic assessment and patient self assessment.	6 months
Physician Photographic Assessment Scale	(+3 = Excellent Improvement, +2 = moderately improvement , +1 = mild improvement, 0 = no change, -1 = mild worsening, -2 =moderate worsening, -3 = severe worsening)	6 months
Patient Satisfaction Scale	-3 Very Unsatisfied, -2 Moderately Unsatisfied, -1 Slightly Unsatisfied, 0 No Change, 1 Slightly Satisfied, 2 Moderately Satisfied, 3 Very Satisfied	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Safety	It is defined as the incidence and severity of adverse events associated with oral and topical minoxidil over the treatment period. This includes localised adverse effects, such as eczema, scalp irritation, light headedness, headache or hypertrichosis, and systemic adverse effects, such as tachycardia, fluid retention and allergic reactions. All information will be recorded in a predesigned proforma.	6 months
Severity of adverse effect (mild, moderate, severe)	Each adverse effect will be categorized as Mild, Moderate and Severe: Mild: No interference with daily activities; may include mild scalp itching or irritation Moderate: Requires intervention (e.g., symptomatic treatment) but allows continuation of minoxidil. Severe: Interferes significantly with daily activities or presents a risk to the patient's health, potentially requiring cessation of treatment (e.g. persistent tachycardia or severe allergic reaction).	6 months

Collaborators and Investigators

• Sponsor: Sheikh Zayed Federal Postgraduate Medical Institute

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Minoxidil; Androgenic Alopecia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Dosage Forms; Piperidines; Pyrimidines; Minoxidil; Capsules
• Other Study ID Numbers: 02-TERC/NHRC-SZH/Int-SC/651

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No