Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata
Information source: King Saud University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alopecia Totalis; Alopecia Universalis; Ophiasic Alopecia
Intervention: methylprednisolone sodium succinate (Drug); methylprednisolone sodium succinate (Drug); methylprednisolone sodium succinate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: King Saud University Official(s) and/or principal investigator(s): Ghada A Binsaif, MD, Principal Investigator, Affiliation: King Saud University
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.
Clinical Details
Official title: Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: hair regrowth
Secondary outcome: Safety of the protocolFactors affect the response to treatment
Detailed 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.
Eligibility
Minimum age: 5 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
King Khalid University Hospital, Riyadh 11472, Saudi Arabia
Additional Information
Starting date: January 2003
Last updated: July 21, 2010
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