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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


N/A
N/A
N/A
Not Enrolling
Both
Basal Cell Carcinoma, Keratosis Palmaris et Plantaris, Psoriasis

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Trial Information

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.

Inclusion 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).

Type of Study:

Observational

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

770172

NCT ID:

NCT00005660

Start Date:

October 1977

Completion Date:

November 2001

Related Keywords:

  • Basal Cell Carcinoma
  • Keratosis Palmaris et Plantaris
  • Psoriasis
  • Hypertriglyceridemia
  • Teratogenicity
  • Ichthyosis
  • Darier's Disease
  • Retinoids
  • Skin
  • Psoriasis
  • Basal cell carcinoma
  • Skin Cancer
  • Carcinoma
  • Carcinoma, Basal Cell
  • Keratoderma, Palmoplantar, Diffuse
  • Keratoderma, Palmoplantar
  • Keratosis
  • Keratosis, Actinic
  • Psoriasis
  • Skin Diseases
  • Hamartoma Syndrome, Multiple

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892