Precancerous Condition Clinical Trial
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
Verified date | May 2007 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | Medizinische Klinik | Munich (Muenchen) | |
United Kingdom | Guy's, King's and St. Thomas' Hospitals Trust | London | England |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Quality Research Group | Miami Beach | Florida |
United States | University of Minnesota Medical School | Minneapolis | Minnesota |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Office of Gerald Bernstein | Seattle | Washington |
United States | State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York |
Lead Sponsor | Collaborator |
---|---|
Applied Genetics |
United States, Germany, United Kingdom,
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