Androgenic Alopecia
Conditions
Keywords
Androgenic Alopecia, Minoxidil
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
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
Sponsors
Sheikh Zayed Federal Postgraduate Medical Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of drug | 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. |
| Physician Photographic Assessment Scale | 6 months | (+3 = Excellent Improvement, +2 = moderately improvement , +1 = mild improvement, 0 = no change, -1 = mild worsening, -2 =moderate worsening, -3 = severe worsening) |
| Patient Satisfaction Scale | 6 months | -3 Very Unsatisfied, -2 Moderately Unsatisfied, -1 Slightly Unsatisfied, 0 No Change, 1 Slightly Satisfied, 2 Moderately Satisfied, 3 Very Satisfied |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Safety | 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. |
| Severity of adverse effect (mild, moderate, severe) | 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). |
Outcome results
None listed