T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum
- Conditions
- Precancerous Condition
- Registration Number
- NCT00002811
- Lead Sponsor
- Applied Genetics
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
University of Minnesota Medical School
🇺🇸Minneapolis, Minnesota, United States
Office of Gerald Bernstein
🇺🇸Seattle, Washington, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Guy's, King's and St. Thomas' Hospitals Trust
🇬🇧London, England, United Kingdom
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Quality Research Group
🇺🇸Miami Beach, Florida, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Medizinische Klinik
🇩🇪Munich (Muenchen), Germany