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
2 Years
60 Years
Both
Precancerous Condition
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Principal Investigator
Daniel B. Yarosh, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Applied Genetics
Authority:
United States: Federal Government
Study ID:
CDR0000064945
NCT ID:
NCT00002811
Start Date:
July 1996
Completion Date:
Related Keywords:
- Precancerous Condition
- actinic keratosis
- Keratosis
- Keratosis, Actinic
- Precancerous Conditions
- Ichthyosis
- Xeroderma Pigmentosum
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
| University of Minnesota Medical School | Minneapolis, Minnesota 55455 |
| Quality Research Group | Miami Beach, Florida 33140 |
| Office of Gerald Bernstein | Seattle, Washington 98107 |
