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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


Phase 3
2 Years
60 Years
Open (Enrolling)
Both
Precancerous Condition

Thank you

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 CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Washington University School of MedicineSaint Louis, Missouri  63110
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
University of Minnesota Medical SchoolMinneapolis, Minnesota  55455
Quality Research GroupMiami Beach, Florida  33140
Office of Gerald BernsteinSeattle, Washington  98107