T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum
This trial is active, not recruiting.
|Treatment||liposomal t4n5 lotion|
|Start date||July 1996|
|Trial size||30 participants|
|Trial identifier||NCT00002811, AGI-007, AGI-FDR000992, CDR0000064945, NCI-V96-0953|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Miami Beach, FL||Quality Research Group||no longer recruiting|
|Ann Arbor, MI||University of Michigan Comprehensive Cancer Center||no longer recruiting|
|Minneapolis, MN||University of Minnesota Medical School||no longer recruiting|
|Saint Louis, MO||Washington University School of Medicine||no longer recruiting|
|Stony Brook, NY||State University of New York Health Sciences Center - Stony Brook||no longer recruiting|
|Houston, TX||University of Texas - MD Anderson Cancer Center||no longer recruiting|
|Seattle, WA||Office of Gerald Bernstein||no longer recruiting|
|Munich (Muenchen), Germany||Medizinische Klinik||no longer recruiting|
|London, United Kingdom||Guy's, King's and St. Thomas' Hospitals Trust||no longer recruiting|
Male or female participants from 2 years up to 60 years old.
DISEASE CHARACTERISTICS: Diagnosis of xeroderma pigmentosum confirmed by unscheduled DNA synthesis assay At least one histologically confirmed actinic keratosis All actinic keratoses removed prior to treatment No associated syndromes, e.g., Cockayne's syndrome or trichothiodystrophy 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
|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|
|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.|
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