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