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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004690
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

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.

Condition or disease Intervention/treatment Phase
Ichthyosis Drug: monolaurin cream Phase 3

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.

Completion date provided represents the completion date of the grant per OOPD records

Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : September 1996
Study Completion Date : September 1998

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004690

Sponsors and Collaborators
Cellegy Pharmaceuticals
Study Chair: Carl R. Thornfeldt Cellegy Pharmaceuticals Identifier: NCT00004690     History of Changes
Other Study ID Numbers: 199/13316
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 1999

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

Additional relevant MeSH terms:
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Skin Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs