Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata

Study Overview
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Brief Summary
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Systemic Pulse Glucocorticoids have been shown to be effective in widespread Alopecia areata but not the totalis, universalis or ophiasic type. Whether the failure is due to inadequate dosing, inadequate frequency or other factors is a matter of debate. The investigators decided to conduct this study using the oral pulse steroid, however with higher doses and more frequent pulses to patients with severe forms of Alopecia areata.

Detailed Description
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This will be a single-center, prospective, randomized study conducted in King Khalid University Hospital. Patients diagnosed with either Alopecia universalis, Alopecia totalis or Ophiasic alopecia will be included in the study. Patients with contraindications such as diabetes mellitus, peptic ulcer, hypertension, infection, psychosis, heart or kidney disease, endocrine disorders (apart from a subclinical hypothyroidism and autoimmune thyroiditis) will be excluded. Children less than 5 years of age and those who received systemic or topical treatment within the last 4 weeks before enrollment will be also excluded. Those of child bearing potential had to have a negative urine pregnancy test result at baseline visit and should practice a reliable method of contraception throughout the study. 42 eligible patients will be randomly assigned to one of 3 treatment groups. Enrolled patients must provide written informed consent. Institutional review board approval will be obtained.

Official Title
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Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata

Conditions
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Alopecia Totalis, Alopecia Universalis, Ophiasic Alopecia

Intervention / Treatment
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* Drug: methylprednisolone sodium succinate
* Drug: methylprednisolone sodium succinate
* Drug: methylprednisolone sodium succinate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alopecia Universalis Alopecia Totalis Ophiasic Alopecia Exclusion Criteria: diabetes mellitus peptic ulcer hypertension infection psychosis heart disease kidney disease endocrine disorders (apart from a subclinical hypothyroidism and autoimmune thyroiditis) received systemic or topical treatment within the last 4 weeks before enrollment pregnancy

Ages Eligible for Study
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Minimum Age: 5 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>will receive pulse treatment for 3 consecutive days once every 2 weeks for 24 weeks | Drug: methylprednisolone sodium succinate<br>* Group A will receive pulse treatment for 3 consecutive days once every 2 weeks for 24 weeks. The daily dose of each pulse treatment will consist of methylprednisolone sodium succinate 15mg/kg of ideal body weight, given orally in 200 ml of fresh orange juice.<br>|
| Active Comparator: Group B<br>will receive 2 consecutive daily pulses every 3 weeks for 24 weeks | Drug: methylprednisolone sodium succinate<br>* Group B will receive 2 consecutive daily pulses every 3 weeks for 24 weeks. The daily dose of each pulse treatment will consist of methylprednisolone sodium succinate 15mg/kg of ideal body weight, given orally in 200 ml of fresh orange juice.<br>|
| Active Comparator: Group C<br>will receive 3 consecutive daily pulses every 3 weeks for 24 weeks. | Drug: methylprednisolone sodium succinate<br>* Group C will receive 3 consecutive daily pulses every 3 weeks for 24 weeks. The daily dose of each pulse treatment will consist of methylprednisolone sodium succinate 15mg/kg of ideal body weight, given orally in 200 ml of fresh orange juice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hair regrowth | Photographs of scalp will be taken before treatment and every 2 visits. Analysis of the photographs will be conducted by two independent dermatologists. Primary efficacy measure will be the proportion of responders at 36 weeks. | at 36 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the protocol | Patients will be monitored for signs and symptoms of adverse events throughout study. Weight, temperature and blood pressure,Electrocardiography and serum electrolytes will be assessed at each visit. The followings will be also performed at specified time frame: complete blood count, blood biochemistry, electrocardiography, Chest x-ray, sinuses x-ray, Short synactin test, Bone mineral density and ophthalmologic examination. | from the first visit till one year after discontinuation of treatment | 
| Factors affect the response to treatment | Responses will be analyzed in relation to clinical findings and presence of subclinical hypothyroidism, thyroid auto antibodies, antinuclear antibodies, ferritin level, IgE level and the presence and degree of dermal fibrosis, inflammation and epidermal follicular plugging | at 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alopecia Areata, Alopecia totalis, Alopecia Universalis, Ophiasic alopecia, Oral Pulse steroid, Methylprednisolone