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The Evaluation of Oral Acitretin in the Treatment of Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas and Other Retinoid Responsive Diseases ClinicalTrials.gov Identifier: NCT00005660 The safety and scientific validity of this study is the responsibility of the
Recruitment Status : Completed
study sponsor and investigators. Listing a study does not mean it has been
First Posted : May 15, 2000
evaluated by the U.S. Federal Government. Read our disclaimer for details.
Last Update Posted : March 4, 2008
Sponsor: National Cancer Institute (NCI) Information provided by: National Institutes of Health Clinical Center (CC)
Study Details
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Study Description
No Results Posted
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Brief Summary: This is a continuing study which evaluates the long-term safety and efficacy of oral acitretin in an open manner in the treatment of psoriasis, cutaneous disorders of keratinization, multiple basal cell carcinomas and other retinoid responsive diseases. Condition or disease
Basal Cell Carcinoma Keratosis Palmaris et Plantaris Psoriasis
Detailed Description: This is a continuing study which evaluates the long-term safety and efficacy of oral acitretin in an open manner in the treatment of psoriasis, cutaneous disorders of keratinization, multiple basal cell carcinomas and other retinoid responsive diseases.
Study Design
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Estimated Enrollment : 130 participants Official Title: The Evaluation of Oral Acitretin in the Treatment of Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas and Other Retinoid Responsive Diseases Study Start Date : October 1977 Estimated Study Completion Date : November 2001
Resource links provided by the National Library of Medicine Genetics Home Reference related topics: 9q22.3 microdeletion Bart-Pumphrey syndrome Cole disease Gorlin syndrome Vohwinkel syndrome Palmoplantar keratoderma with deafness MedlinePlus related topics: Psoriasis Skin Conditions Drug Information available for: Acitretin Genetic and Rare Diseases Information Center resources: Tylosis Nevoid Basal Cell Carcinoma Syndrome Darier Disease Basal Cell Carcinoma, Multiple Palmoplantar Keratoderma U.S. FDA Resources
Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: Child, Adult, Senior Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria
Patients with widespread involvement (e.g. psoriasis patients with 10 percent or more of body surface area involved) or with severe, recalcitrant localized involvement with a cutaneous disorder (e.g. keratoderma palmaris et plantaris). Patients (and parents of patients who are less than 18 years old) must be advised of presently available alternative forms of therapy. Patient must be available for and agreeable to regular follow up examinations in the clinic for clinical evaluation, blood tests, diagnostic x-rays and possibly skin biopsies. The patient (and parent, guardian, or surrogate where appropriate) must give written informed consent after protocol, including its limitations and risks, are thoroughly discussed with the patients (and parents). Patients who have multiple skin cancers because of xeroderma pigmentosum (XP). No patients with persistently abnormal (SGOT or SGPT greater than 3 times the upper limit of normal) liver function tests. No patients with persistent pre-treatment hypertriglyceridemia (greater than 300 mg/dl). No patients with persistently abnormal (creatinine greater than 3 times the upper limit of normal) renal function tests. No patients with presence of a significant neurological, musculoskeletal or other internal medical disorder which may be aggravated by the addition of retinoid therapy. Patient must not be pregnant or anticipate such an event. Because of the long-term storage of etretinate, a known teratogen, fertile women who may be treated in this protocol, must have skin disease that is severe and recalcitrant to all other standard modalities. These women must also use an effective form of contraception (oral contraceptives or an intrauterine device) while on treatment and at least for 3 years post treatment. No patients with chronic intake of excessive dietary vitamin A (more than 25,000 iu/day).
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00005660
Locations United States, Maryland
National Cancer Institute (NCI) Bethesda, Maryland, United States, 20892 Sponsors and Collaborators
National Cancer Institute (NCI)
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ClinicalTrials.gov Identifier: NCT00005660 History of Changes Obsolete Identifiers:
NCT00020956
Other Study ID Numbers:
770172 77-C-0172
First Posted:
May 15, 2000 Key Record Dates
Last Update Posted:
March 4, 2008
Last Verified:
November 2001
Keywords provided by National Institutes of Health Clinical Center (CC): Hypertriglyceridemia
Skin
Teratogenicity
Psoriasis
Ichthyosis
Basal cell carcinoma
Darier's Disease
Skin Cancer
Retinoids Additional relevant MeSH terms: Carcinoma
Jaw Cysts
Psoriasis
Bone Cysts
Keratosis
Cysts
Carcinoma, Basal Cell
Neoplastic Syndromes, Hereditary
Basal Cell Nevus Syndrome
Bone Diseases, Developmental
Hamartoma Syndrome, Multiple
Bone Diseases
Skin Diseases
Musculoskeletal Diseases
Keratoderma, Palmoplantar
Jaw Diseases
Keratoderma, Palmoplantar, Diffuse
Stomatognathic Diseases
Neoplasms, Glandular and Epithelial
Abnormalities, Multiple
Neoplasms by Histologic Type
Congenital Abnormalities
Neoplasms
Genetic Diseases, Inborn
Skin Diseases, Papulosquamous
Hamartoma
Neoplasms, Basal Cell
Neoplasms, Multiple Primary
Odontogenic Cysts
Skin Diseases, Genetic