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Completed

NCT Number: NCT01167946

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

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.

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Key information

Conditions

Alopecia Totalis Alopecia Alopecia Areata Alopecia Universalis Hair Diseases Hypotrichosis Ophiasic Alopecia Skin Diseases Skin and Connective Tissue Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King Khalid University Hospital

Riyadh, Riyadh Region, 11472, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone Sodium Succinate

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Collaborators

  • Saudi Society of Dermatology and Dermatologic surgery

Registry information

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
Jul 22, 2010
Registry last updated
Jul 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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