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

This study has been completed.
Sponsor:
Collaborator:
Saudi Society of Dermatology and Dermatologic surgery
Information provided by:
King Saud University
ClinicalTrials.gov Identifier:
NCT01167946
First received: July 21, 2010
Last updated: NA
Last verified: January 2003
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Alopecia Totalis
Alopecia Universalis
Ophiasic Alopecia
Drug: methylprednisolone sodium succinate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata

Resource links provided by NLM:


Further study details as provided by King Saud University:

Primary Outcome Measures:
  • hair regrowth [ Time Frame: at 36 weeks of treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety of the protocol [ Time Frame: from the first visit till one year after discontinuation of treatment ] [ Designated as safety issue: Yes ]
    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.

  • Factors affect the response to treatment [ Time Frame: at 36 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 42
Study Start Date: January 2003
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Active Comparator: Group B
will receive 2 consecutive daily pulses every 3 weeks for 24 weeks
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.
Active Comparator: Group C
will receive 3 consecutive daily pulses every 3 weeks for 24 weeks.
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.

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

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167946

Locations
Saudi Arabia
King Khalid University Hospital
Riyadh, Saudi Arabia, 11472
Sponsors and Collaborators
King Saud University
Saudi Society of Dermatology and Dermatologic surgery
Investigators
Principal Investigator: Ghada A Binsaif, MD King Saud University
  More Information

No publications provided

Responsible Party: Ghada Binsaif, King Saud University
ClinicalTrials.gov Identifier: NCT01167946     History of Changes
Other Study ID Numbers: 03-451
Study First Received: July 21, 2010
Last Updated: July 21, 2010
Health Authority: Saudi Arabia: King Saud University

Keywords provided by King Saud University:
Alopecia Areata
Alopecia totalis
Alopecia Universalis
Ophiasic alopecia
Oral Pulse steroid
Methylprednisolone

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014