The Evaluation of Oral Acitretin in the… | Clinical Trial

Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Darier Disease Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hypertriglyceridemia Ichthyosis Infant, Newborn, Diseases Keratoderma, Palmoplantar Keratosis Keratosis Palmaris et Plantaris Lipid Metabolism Disorders Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Psoriasis Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Papulosquamous Skin Neoplasms Skin and Connective Tissue Diseases Teratogenesis

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Important dates

Study start: 1977
Study completion: 2001
First posted: May 15, 2000
Registry last updated: Mar 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed