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NCT Number: NCT07273799

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

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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Key information

Conditions

Androgenic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Minoxidil 5 % Topical Spray

Drug

Topical spray on hairs

minoxidil

Drug

Oral minoxidil 2.5mg

Placebo Spray

Drug

placebo spray

Placebo Tablet or Capsule

Drug

Placebo tablet

Primary outcomes

  1. Efficacy of drug

    Time frame: 6 months

    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.

  2. Physician Photographic Assessment Scale

    Time frame: 6 months

    (+3 = Excellent Improvement, +2 = moderately improvement , +1 = mild improvement, 0 = no change, -1 = mild worsening, -2 =moderate worsening, -3 = severe worsening)

  3. Patient Satisfaction Scale

    Time frame: 6 months

    -3 Very Unsatisfied, -2 Moderately Unsatisfied, -1 Slightly Unsatisfied, 0 No Change, 1 Slightly Satisfied, 2 Moderately Satisfied, 3 Very Satisfied

Secondary outcomes

  1. Drug Safety

    Time frame: 6 months

    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.

  2. Severity of adverse effect (mild, moderate, severe)

    Time frame: 6 months

    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).

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Federal Postgraduate Medical Institute

Other

Registry information

Acronym: mina

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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