Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata
- Conditions
- Alopecia TotalisAlopecia UniversalisOphiasic Alopecia
- Interventions
- Registration Number
- NCT01167946
- Lead Sponsor
- King Saud University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Alopecia Universalis
- Alopecia Totalis
- Ophiasic Alopecia
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A methylprednisolone sodium succinate will receive pulse treatment for 3 consecutive days once every 2 weeks for 24 weeks Group B methylprednisolone sodium succinate will receive 2 consecutive daily pulses every 3 weeks for 24 weeks Group C methylprednisolone sodium succinate will receive 3 consecutive daily pulses every 3 weeks for 24 weeks.
- Primary Outcome Measures
Name Time Method hair regrowth 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 Outcome Measures
Name Time Method Safety of the protocol 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.
Factors affect the response to treatment 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
Trial Locations
- Locations (1)
King Khalid University Hospital
🇸🇦Riyadh, Saudi Arabia