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

Phase 3Not Yet RecruitingNCT07273799

Sheikh Zayed Federal Postgraduate Medical Institute200 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Androgenic Alopecia

Interventions

Minoxidil 5 % Topical SprayDRUG

Topical spray on hairs

minoxidilDRUG

Oral minoxidil 2.5mg

Placebo SprayDRUG

placebo spray

Placebo Tablet or Capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 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)

Time frame: 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

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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).

Time frame: 6 months

Data from ClinicalTrials.gov

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