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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00002811 |
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Date of registration:
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01/11/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum
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Scientific title:
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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 |
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Date of first enrolment:
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July 1996 |
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Target sample size:
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30 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00002811 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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United Kingdom
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United States
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Contacts
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Name:
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Daniel B. Yarosh, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Applied Genetics |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Precancerous Condition
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Intervention(s)
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Drug: liposomal T4N5 lotion
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Secondary ID(s)
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NCI-V96-0953
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CDR0000064945
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AGI-007
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AGI-FDR000992
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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