A RANDOMIZED, DOUBLE BLIND, MULTI-CENTER CLINICAL STUDY TO TEST THE SAFETY AND EFFICACY OF T4N5 LIPOSOME LOTION ON PATIENTS WITH XERODERMA PIGMENTOSUM IN THE PROTECTION AGAINST ACTINIC KERATOSES
OBJECTIVES: I. Compare the safety and efficacy of T4N5 liposome lotion vs. a placebo lotion
in reducing the incidence of actinic keratoses and protecting against other ultraviolet skin
damage in patients with xeroderma pigmentosum.
OUTLINE: Randomized, double-blind study. Groups of 6 patients are randomly assigned in a 2:1
ratio to Arms I and II, respectively. Arm I: Chemoprevention. Lotion composed of T4
endonuclease V protein encapsulated in liposomes and suspended in phosphate-buffered saline
in a hydrogel base, T4N5 Liposome Lotion, T4N5. Arm II: Control. Liposomes suspended in
phosphate-buffered saline in a hydrogel base, Placebo, PLCB.
PROJECTED ACCRUAL: 6-30 patients will be entered in this multicenter study.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Daniel B. Yarosh, PhD
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|State University of New York Health Sciences Center - Stony Brook||Stony Brook, New York 11790-7775|
|University of Minnesota Medical School||Minneapolis, Minnesota 55455|
|Quality Research Group||Miami Beach, Florida 33140|
|Office of Gerald Bernstein||Seattle, Washington 98107|