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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 protocol

Factors 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

Page last updated: August 23, 2015

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