Skin Carcinoma Clinical Trial
Official title:
A Phase II Randomized, Double-Blind, Vehicle-Controlled, Crossover Clinical Trial of Tazarotene 0.1% and Vehicle Cream Each Applied Once-Daily for 12 or 24 Months in Subjects With Basal Cell Nevus Syndrome
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 randomized phase II trial is comparing two different schedules of topical
tazarotene and topical placebo to see how well they work in treating patients with basal
cell skin cancer and basal cell nevus syndrome on the chest.
OBJECTIVES:
Primary
- To expand and refine chemopreventive strategies in individuals with basal cell nevus
syndrome (BCNS) on the chest and back, who are at high risk for the development of
basal cell carcinomas (BCCs).
- To determine whether tazarotene 0.1% cream applied to the chest for two years will
reduce the numbers of basal cell carcinomas (BCCs) observed, as compared to the number
expected, based on changes in BCC numbers observed during months 0-12.
Secondary
- To compare the difference in total BCC burden (measured as the total lesion surface
area) between chest and back over various time points and aggregated intervals of
interest.
- To determine whether there are any detectable wash-in or wash-out periods for the
tazarotene effects.
- Explore the use of a random effects model for longitudinal analysis of total lesions
over time.
OUTLINE: This is a multicenter study. Patients are randomized into 1 of 2 arms.
- Arm I: Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on
months 13-36 once daily to the chest in the absence of disease progression or
unacceptable toxicity.
- Arm II: Patients apply vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on
months 13-36 once daily to the chest in the absence of disease progression or
unacceptable toxicity.
Treated chest and untreated back is evaluated at 3 month intervals for 36 months.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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