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T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum
This study is ongoing, but not recruiting participants.
Study NCT00002811   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes

November 1, 1999
July 23, 2008
July 1996
 
 
 
Complete list of historical versions of study NCT00002811 on ClinicalTrials.gov Archive Site
 
 
 
T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum
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.

Phase III
Interventional
Prevention, Randomized, Double-Blind
Precancerous/Nonmalignant Condition
Drug: T4N5 liposomal lotion
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
30
 
 

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

Both
2 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   United Kingdom
 
NCT00002811
 
CDR0000064945, AGI-007, AGI-FDR000992, NCI-V96-0953
Applied Genetics
 
Study Chair: Daniel B. Yarosh, PhD Applied Genetics
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP