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

NCT07273799 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 02-TERC/NHRC-SZH/Int-SC/651
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Androgenic Alopecia

Keywords

Androgenic Alopecia; Minoxidil

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Drug Safety

  6 months

• Severity of adverse effect (mild, moderate, severe)

  6 months

Study Arms (4)

Disease Control

PLACEBO COMPARATOR

Placebo spray and palcebo tablet

Drug: Placebo Spray; Drug: Placebo Tablet or Capsule

Minoxidil Spray Arm

ACTIVE COMPARATOR

Placebo tablet Mixidil spray

Drug: Minoxidil 5 % Topical Spray; Drug: Placebo Tablet or Capsule

Minoxidil Tablet Arm

ACTIVE COMPARATOR

Mixidil tablet placebo spray

Drug: minoxidil; Drug: Placebo Spray

Minoxidil Tablet + Spray Arm

EXPERIMENTAL

Minoxidil spray Minoxidil Tablet

Drug: Minoxidil 5 % Topical Spray; Drug: minoxidil

Interventions

minoxidil DRUG

Oral minoxidil 2.5mg

Minoxidil Tablet + Spray Arm; Minoxidil Tablet Arm

Minoxidil 5 % Topical Spray DRUG

Topical spray on hairs

Minoxidil Spray Arm; Minoxidil Tablet + Spray Arm

Placebo Spray DRUG

placebo spray

Disease Control; Minoxidil Tablet Arm

Placebo Tablet or Capsule DRUG

Placebo tablet

Disease Control; Minoxidil Spray Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• to 50 years of age
• Willing to provide informed consent
• Willing to not use any other hair loss treatment during the treatment period

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sheikh Zayed Federal Postgraduate Medical Institute: lead

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Capsules

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 10, 2025
• Study Start: December 20, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share