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Trial record 1 of 2 for:    "palmoplantar keratoderma with deafness" OR "Keratoderma, Palmoplantar"
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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005660
First Posted: May 15, 2000
Last Update Posted: March 4, 2008
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.
Information provided by:
National Institutes of Health Clinical Center (CC)
May 12, 2000
May 15, 2000
March 4, 2008
October 1977
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Complete list of historical versions of study NCT00005660 on ClinicalTrials.gov Archive Site
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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
The Evaluation of Oral Acitretin in the Treatment of Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas and Other Retinoid Responsive Diseases
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.
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.
Observational
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  • Basal Cell Carcinoma
  • Keratosis Palmaris et Plantaris
  • Psoriasis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
November 2001
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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).

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00005660
770172
77-C-0172
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National Cancer Institute (NCI)
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National Institutes of Health Clinical Center (CC)
November 2001