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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.
First Received: May 12, 2000   Last Updated: March 3, 2008   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00005660
  Purpose

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
Basal Cell Carcinoma
Keratosis Palmaris et Plantaris
Psoriasis

Genetics Home Reference related topics: Darier disease pachyonychia congenita
MedlinePlus related topics: Cancer Psoriasis Skin Conditions
Drug Information available for: Acitretin
U.S. FDA Resources
Study Type: Observational
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

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 130
Study Start Date: October 1977
Estimated Study Completion Date: November 2001
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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005660

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

No publications provided

Study ID Numbers: 770172, 77-C-0172
Study First Received: May 12, 2000
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00005660     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Hypertriglyceridemia
Teratogenicity
Ichthyosis
Darier's Disease
Retinoids
Skin
Psoriasis
Basal cell carcinoma
Skin Cancer

Study placed in the following topic categories:
Palmoplantar Keratoderma, Epidermolytic
Keratosis
Hypertriglyceridemia
Skin Diseases
Darier's Disease
Basal Cell Carcinoma, Multiple
Keratoderma, Palmoplantar
Carcinoma, Basal Cell
Lamellar Ichthyosis
Skin Neoplasms
Palmoplantar Keratoderma
Ichthyosis
Carcinoma
Keratoderma, Palmoplantar, Diffuse
Keratosis Follicularis
Genetic Diseases, Inborn
Psoriasis
Neoplasms, Basal Cell
Acitretin
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Tylosis
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Keratosis
Neoplasms by Histologic Type
Skin Diseases
Keratoderma, Palmoplantar
Carcinoma, Basal Cell
Carcinoma
Keratoderma, Palmoplantar, Diffuse
Neoplasms
Genetic Diseases, Inborn
Psoriasis
Neoplasms, Basal Cell
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009