T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum
NCT ID: NCT00002811
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
1996-07-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PREVENTION
DOUBLE
Interventions
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liposomal T4N5 lotion
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 1.66 to 60 Other: Good general health and mental capacity No illegal drug use No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY: See Disease Characteristics
2 Years
60 Years
ALL
No
Sponsors
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Applied Genetics
INDUSTRY
Principal Investigators
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Daniel B. Yarosh, PhD
Role: STUDY_CHAIR
Applied Genetics
Locations
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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
St 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
Countries
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Other Identifiers
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AGI-007
Identifier Type: -
Identifier Source: secondary_id
AGI-FDR000992
Identifier Type: -
Identifier Source: secondary_id
NCI-V96-0953
Identifier Type: -
Identifier Source: secondary_id
CDR0000064945
Identifier Type: -
Identifier Source: org_study_id