Phase III Study of Monolaurin Cream Therapy for Patients With Congenital Ichthyosis - Full Text View

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	Cellegy Pharmaceuticals
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004690

Purpose

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.

Condition	Intervention	Phase
Ichthyosis	Drug: monolaurin cream	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Resource links provided by NLM:

Drug Information available for: Monolaurin

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	90
Study Start Date:	September 1996

Detailed Description:

PROTOCOL OUTLINE: This is a three month, randomized, double blind, placebo controlled study followed by a nine month, open label, rollover study.

Patients are treated either with a placebo vehicle cream or the study cream, monolaurin (15% glyceryl monolaurate), for 3 months followed by a four week break. Medications are applied uniformly twice daily (morning and at least 1 hour before bedtime). After this blinded portion of the study, all patients are administered monolaurin cream for 9 months.

Patients are followed for 4 weeks after the last cream application.

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004690

Sponsors and Collaborators

FDA Office of Orphan Products Development

Cellegy Pharmaceuticals

Investigators

Study Chair:

Carl R. Thornfeldt

Cellegy Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	199/13316, CELLEGY-FDR001278
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004690 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

dermatologic disorders
ichthyosis
rare disease

Additional relevant MeSH terms:

Keratosis
Cariostatic Agents
Skin Diseases
Monolaurin
Physiological Effects of Drugs
Skin Abnormalities

Infant, Newborn, Diseases
Congenital Abnormalities
Protective Agents
Ichthyosis
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009