Back to resultsT4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum
Primary Purpose
Precancerous Condition
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
liposomal T4N5 lotion
Sponsored by
About this trial
This is an interventional prevention trial for Precancerous Condition focused on measuring actinic keratosis
Eligibility Criteria
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
Sites / Locations
- Quality Research Group
- University of Michigan Comprehensive Cancer Center
- University of Minnesota Medical School
- Washington University School of Medicine
- State University of New York Health Sciences Center - Stony Brook
- University of Texas - MD Anderson Cancer Center
- Office of Gerald Bernstein
- Medizinische Klinik
- Guy's, King's and St. Thomas' Hospitals Trust
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002811
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 Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Applied Genetics
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precancerous Condition
Keywords
actinic keratosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
liposomal T4N5 lotion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel B. Yarosh, PhD
Organizational Affiliation
Applied Genetics
Official's Role
Study Chair
Facility Information:
Facility Name
Quality Research Group
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0752
Country
United States
Facility Name
University of Minnesota Medical School
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
State University of New York Health Sciences Center - Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790-9832
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Office of Gerald Bernstein
City
Seattle
State/Province
Washington
ZIP/Postal Code
98107
Country
United States
Facility Name
Medizinische Klinik
City
Munich (Muenchen)
ZIP/Postal Code
D-80336
Country
Germany
Facility Name
Guy's, King's and St. Thomas' Hospitals Trust
City
London
State/Province
England
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
12. IPD Sharing Statement
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T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum
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