Precancerous Condition Clinical Trial
Official title:
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
RATIONALE: Patients with xeroderma pigmentosum are more likely to develop skin lesions in
sun-affected areas. These skin lesions, such as actinic keratoses, can develop into skin
cancer. T4N5 liposome lotion may reduce actinic keratoses or other sun-induced skin damage
in patients with xeroderma pigmentosum.
PURPOSE: Randomized double-blinded phase III trial to compare treatment using T4N5 liposome
lotion with treatment using placebo in reducing actinic keratoses and other sun-induced skin
damage in patients with xeroderma pigmentosum.
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
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