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
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
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
Parallel
Minoxidil 5 % Topical Spray
DrugTopical spray on hairs
minoxidil
DrugOral minoxidil 2.5mg
Placebo Spray
Drugplacebo spray
Placebo Tablet or Capsule
DrugPlacebo tablet
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.
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)
Patient Satisfaction Scale
-3 Very Unsatisfied, -2 Moderately Unsatisfied, -1 Slightly Unsatisfied, 0 No Change, 1 Slightly Satisfied, 2 Moderately Satisfied, 3 Very Satisfied
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.
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).
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