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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disease Control | Placebo Comparator | Placebo spray and palcebo tablet |
|
| Minoxidil Spray Arm | Active Comparator | Placebo tablet Mixidil spray |
|
| Minoxidil Tablet Arm | Active Comparator | Mixidil tablet placebo spray |
|
| Minoxidil Tablet + Spray Arm | Experimental | Minoxidil spray Minoxidil Tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minoxidil 5 % Topical Spray | Drug | Topical spray on hairs |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| minoxidil | Drug | Oral minoxidil 2.5mg |
|
| Placebo Spray | Drug | placebo spray |
|
| Placebo Tablet or Capsule | Drug | Placebo tablet |
|
| 6 months |
| 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). | 6 months |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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