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

King Saud University

Status and phase: Completed; Phase 4

Conditions: Alopecia Totalis; Ophiasic Alopecia; Alopecia Universalis

Treatments: Drug: methylprednisolone sodium succinate

Study type: Interventional

Funder types: Other

Identifiers

NCT01167946

03-451

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 3 patient groups

Group A

Experimental group

Description:

will receive pulse treatment for 3 consecutive days once every 2 weeks for 24 weeks

Treatment:

Drug: methylprednisolone sodium succinate

Drug: methylprednisolone sodium succinate

Drug: methylprednisolone sodium succinate

Group B

Active Comparator group

Description:

will receive 2 consecutive daily pulses every 3 weeks for 24 weeks

Treatment:

Drug: methylprednisolone sodium succinate

Drug: methylprednisolone sodium succinate

Drug: methylprednisolone sodium succinate

Group C

Active Comparator group

Description:

will receive 3 consecutive daily pulses every 3 weeks for 24 weeks.

Treatment:

Drug: methylprednisolone sodium succinate

Drug: methylprednisolone sodium succinate

Drug: methylprednisolone sodium succinate