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

July 21, 2010 updated by: King Saud University
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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11472
        • King Khalid University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
will receive pulse treatment for 3 consecutive days once every 2 weeks for 24 weeks
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.
Active Comparator: Group B
will receive 2 consecutive daily pulses every 3 weeks for 24 weeks
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.
Active Comparator: Group C
will receive 3 consecutive daily pulses every 3 weeks for 24 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hair regrowth
Time Frame: at 36 weeks of treatment
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
Time Frame: from the first visit till one year after discontinuation of treatment
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
Time Frame: at 36 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Collaborators

Saudi Society of Dermatology and Dermatologic surgery

Investigators

  • Principal Investigator: Ghada A Binsaif, MD, King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (Estimate)

July 22, 2010

Study Record Updates

Last Update Posted (Estimate)

July 22, 2010

Last Update Submitted That Met QC Criteria

July 21, 2010

Last Verified

January 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-451

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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