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

NCT01167946 | Completed Phase 4 DMC

• 1 other identifier: 03-451
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Totalis; Alopecia Universalis; Ophiasic Alopecia

Keywords

Alopecia Areata; Alopecia totalis; Alopecia Universalis; Ophiasic alopecia; Oral Pulse steroid; Methylprednisolone

Outcome Measures

Primary Outcomes (1)

• hair regrowth

  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 Outcomes (2)

• Safety of the protocol

  from the first visit till one year after discontinuation of treatment

• Factors affect the response to treatment

  at 36 weeks

Study Arms (3)

Group A

EXPERIMENTAL

will receive pulse treatment for 3 consecutive days once every 2 weeks for 24 weeks

Drug: methylprednisolone sodium succinate

Group B

ACTIVE COMPARATOR

will receive 2 consecutive daily pulses every 3 weeks for 24 weeks

Drug: methylprednisolone sodium succinate

Group C

ACTIVE COMPARATOR

will receive 3 consecutive daily pulses every 3 weeks for 24 weeks.

Drug: methylprednisolone sodium succinate

Interventions

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.

Group A

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Alopecia Universalis
• Alopecia Totalis
• Ophiasic Alopecia

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead
• Saudi Society of Dermatology and Dermatologic surgery: collaborator

Study Sites (1)

King Khalid University Hospital

Riyadh, Riyadh Region, 11472, Saudi Arabia

Location

MeSH Terms

Conditions

Alopecia universalis; Alopecia Areata

Interventions

Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ghada A Binsaif, MD

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: January 1, 2003
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: July 22, 2010

Record last verified: 2003-01

Locations

SA (1)