Erythropoietic Protoporphyria Clinical Trial
OBJECTIVES:
I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing
photosensitivity in patients with erythropoietic protoporphyria.
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study.
Patients are randomly assigned to 1 of 2 groups to receive cysteine hydrochloride orally
twice daily, 2 capsules with breakfast and 2 with lunch. Group 1 receives cysteine
hydrochloride in drug ingestion period 1 followed by placebo in period 2. Group 2 receives
placebo in period 1 followed by cysteine hydrochloride in period 2. Both groups ingest
placebo for 1 week between the periods. Each drug ingestion period lasts 8 weeks.
Follow up phone calls are made at the end of months 1 and 3. All patients schedule follow up
visits at the end of each drug ingestion period.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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