Phase III Study of Monolaurin Cream Therapy for Patients With Congenital Ichthyosis

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Nonbullous congenital ichthyosiform erythroderma (chronic, multifactorial, hyperkeratotic, inflammatory skin disease) Clinical criteria includes: - generalized involvement with no flexural sparing - congenital onset usually as collodion baby (i.e., a taut, shiny encasement which is shed postnatally revealing underlying erythroderma and generalized ichthyosis) - scales should be fine, whitish, and rather loose except on the lower legs where the scales may be large, platelike, and dark - if severely effected: intense erythema is present; overt ectropion may be present; cicatricial alopecia may be present; and secondary nail dystrophies with thickening of nail plate and ridging may be present Phenotypically consistent with diagnostic grading photos Grade of at least 3 for scaling on four treatment sites --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 4 weeks since prior corticosteroids No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified Other: At least 4 weeks since any prior investigational medications At least 4 weeks since any prior systemic therapy, such as hypolipidemics or retinoids Nonglycerin emollients allowed up to 1 week prior to study At least 4 weeks since any other topical therapy including humectants such as urea, alpha hydroxy or alpha ketoacid preparations and retinoids No concurrent topical therapy No concurrent investigational medications --Patient Characteristics-- Age: 18 months and over Performance status: Not specified Hematopoietic: No clinically significant laboratory abnormalities Hepatic: No clinically significant laboratory abnormalities Renal: No clinically significant laboratory abnormalities Other: Triglyceride or total cholesterol no greater than 3 times normal Must be in general good health No known hypersensitivity to any component of this study medication Not pregnant or nursing Adequate contraception required of all fertile women