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Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis Clinical research trials and Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis. Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis clinical trial. Test subjects typically obtain the finest healthcare available for their Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis  Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis
Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis
For Condition: Ichthyosis
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , Cellegy Pharmaceuticals
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 2 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
CarlThornfeldt, Study Chair, Cellegy Pharmaceuticals
Additional Information:
Study ID Numbers: 199/13316; CELLEGY-FDR001278
Study Start Date: September 1996
Record last reviewed: March 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004690
Other Ichthyosis Studies:
1. Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis
2. National Registry for Ichthyosis and Related Disorders
Related Studies:
Other Ichthyosis Clinical Trials
Other Clinical Trials
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Phase III Study of Monolaurin Cream Therapy for Patients with Congenital Ichthyosis
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