Spots Global Cancer Trial Database for T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum
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Trial Identification
Brief Title: T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum
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
Study ID: NCT00002811
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Quality Research Group, Miami Beach, Florida, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
University of Minnesota Medical School, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Office of Gerald Bernstein, Seattle, Washington, United States
Medizinische Klinik, Munich (Muenchen), , Germany
Guy's, King's and St. Thomas' Hospitals Trust, London, England, United Kingdom
Contact Details
Name: Daniel B. Yarosh, PhD
Affiliation: Applied Genetics
Role: STUDY_CHAIR
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