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

NCT01167946 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2010-07-22

No results posted yet for this study

Summary

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.

Conditions

  • Alopecia Totalis
  • Alopecia Universalis
  • Ophiasic Alopecia

Interventions

DRUG

methylprednisolone sodium succinate

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.

DRUG

methylprednisolone sodium succinate

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.

DRUG

methylprednisolone sodium succinate

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.

Sponsors & Collaborators

  • Saudi Society of Dermatology and Dermatologic surgery

    collaborator UNKNOWN

  • King Saud University

    lead OTHER

Principal Investigators

  • Ghada A Binsaif, MD · King Saud University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2009-12-31
Completion
2010-07-31

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01167946 on ClinicalTrials.gov