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

NCT00004690 | Completed Phase 3

• 2 other identifiers: 199/13316CELLEGY-FDR001278
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

OBJECTIVES: I. Compare the safety and efficacy of monolaurin cream versus a placebo vehicle cream in suppressing the signs of nonbullous congenital ichthyosiform erythroderma. II. Assess the incidence of posttreatment rebound or recrudescence in patients with congenital ichthyosis. III. Evaluate the long term safety of monolaurin cream with whole body application in these patients.

Conditions

Ichthyosis

Keywords

dermatologic disorders; ichthyosis; rare disease

Interventions

monolaurin cream DRUG

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cellegy Pharmaceuticals: lead

MeSH Terms

Conditions

Ichthyosis; Skin Diseases; Rare Diseases

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Keratosis; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carl R. Thornfeldt

  Cellegy Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: September 1, 1996
• Study Completion: September 1, 1998
• Last Updated: March 25, 2015

Record last verified: 1999-03