Clinical trial NCT01167946: Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata
Official title: Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alopecia Totalis
Alopecia Universalis
Ophiasic Alopecia
Keywords: Alopecia Areata
Alopecia totalis
Alopecia Universalis
Ophiasic alopecia
Oral Pulse steroid
Methylprednisolone
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: Saudi Society of Dermatology and Dermatologic surgery
First posted: 2010-07-22
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: hair regrowth
timeFrame: at 36 weeks of treatment
Secondary outcomes:
measure: Safety of the protocol
timeFrame: from the first visit till one year after discontinuation of treatment
measure: Factors affect the response to treatment
timeFrame: at 36 weeks
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Khalid University Hospital
Study officials:
affiliation: King Saud University
name: Ghada A Binsaif, MD
role: PRINCIPAL_INVESTIGATOR
References: