Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome… (NCT00489086) | Clinical Trial Compass
CompletedPhase 2
Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face
United States36 participantsStarted 2004-07
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying topical tazarotene to see how well it works in treating patients with basal cell skin cancer and basal cell nevus syndrome on the face.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Study subjects must have at least one basal cell carcinoma ≥ 3mm in diameter (target lesion) on any area of the skin except the face, chest, and back (and not impinging on vital sites) diagnosed clinically by a Study Investigator at the baseline visit.
✓. Study subjects must meet diagnostic criteria for basal cell nevus syndrome including major criterion #1 plus one additional major criterion or two of the minor criteria outlined in Table I. A first degree relative would satisfy BCNS diagnostic criteria with any two major criteria or any single major plus two minor criteria.
✓. More than 2 BCCs or one under the age of 20 years
✓. Odontogenic keratocysts of the jaw proven by histology
✓. Three or more palmar and/or plantar pits
✓. Bilamellar calcification of the falx cerebri (if less than 20 years old)
✓. Fused, bifid, or markedly splayed ribs.
✓. First degree relative with basal cell nevus syndrome (BCNS)
Exclusion criteria
✕. The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study.
✕. The subject has a history of hypersensitivity to any of the ingredients in the study medication formulations.
✕. The subject is unable to return for follow-up tests.
✕. The subject has uncontrolled systemic disease, including known HIV positive patients.
✕. The subject has a history of other skin conditions or significant illness that would interfere with evaluation of the study medication.
✕. Any condition or situation which in the Investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study.
✕. The subject has a history of invasive cancer within the past five years excluding non-melanoma skin cancer, Stage I cervical cancer, or CLL Stage 0.