Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata

Study Overview
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Brief Summary
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Methodology: The 70 patients of age 20 to 50 years presented to the out-patient department of CMH Abbottabad suffering from alopecia areata were enrolled. The non-probability consecutive sampling technique was used. Patient in group-A applied clobetasol propionate 0.05% twice daily, whereas Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months. The Patients were assessed at baseline, 4th weeks, 8th week and 12th week after treatment of each session. Hair loss was calculated from SALT score at presentation and on follow-up after 3 months. The degree of response was assessed on the basis of hair re-growth as excellent (>75% re-growth), Marked (51-75% re-growth), moderate (26-50% re-growth), or slight (≤25% re-growth). To determine statistical significance χ2-square test, taking p-value <0.05 as significant, was used.

Official Title
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Comparative Efficacy of Tacrolimus 0.1% and Clobetasol Propionate 0.05% in the Treatment of Alopecia Areata

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: Group A applied topical Clobetasol Propionate
* Drug: Group B applied topical Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 20 to 50 years Both male and female Duration of illness less than 2 months those who never received any treatment before Exclusion Criteria: Patients having duration of alopecia greater than 2 months Atypical alopecia areata i.e., Alopecia universalis etc Hypersensitivity history to topical corticosteroids or tacrolimus patients taking any systemic immune suppression pregnancy/lactation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A applied Clobetasol Propionate 0.05%<br>Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months. | Drug: Group A applied topical Clobetasol Propionate<br>* Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months<br>|
| Active Comparator: Group B applied topical Tacrolimus 0.1%<br>Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months. | Drug: Group B applied topical Tacrolimus<br>* Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight. | The degree of response was assessed on the basis of hair regrowth as excellent (>75% regrowth), marked (51-75% regrowth), moderate (26-50% regrowth), or slight (≤25% regrowth) | 6 months |