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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 1999 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Cellegy Pharmaceuticals
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004690
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: March 1999
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

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

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

Keywords provided by FDA Office of Orphan Products Development:
dermatologic disorders
ichthyosis
rare disease

Additional relevant MeSH terms:
Ichthyosis
Ichthyosis, Lamellar
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Keratosis
Skin Diseases
Ichthyosiform Erythroderma, Congenital
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Monolaurin
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013