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Not yet recruiting NCT07273799

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

Phase III Interventional Androgenic Alopecia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Minoxidil 5 % Topical Spray, minoxidil, Placebo Spray, Placebo Tablet or Capsule.
Who it may be relevant to
Registry conditions: Androgenic Alopecia. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

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

Interventions

  • Drug Minoxidil 5 % Topical Spray
    Topical spray on hairs
  • Drug minoxidil
    Oral minoxidil 2.5mg
  • Drug Placebo Spray
    placebo spray
  • Drug Placebo Tablet or Capsule
    Placebo tablet

Primary outcome measures

  • Efficacy of drug [Time frame: 6 months]
  • Physician Photographic Assessment Scale [Time frame: 6 months]
  • Patient Satisfaction Scale [Time frame: 6 months]
Secondary outcome measures (2)
  • Drug Safety [Time frame: 6 months]
  • Severity of adverse effect (mild, moderate, severe) [Time frame: 6 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07273799 · 02-TERC/NHRC-SZH/Int-SC/651

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗