NCT00002811

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Geographic Reach
3 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1996

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

September 2, 2004

Completed
Last Updated

November 6, 2013

Status Verified

May 1, 2007

First QC Date

November 1, 1999

Last Update Submit

November 5, 2013

Conditions

Precancerous Condition

Keywords

actinic keratosis

Interventions

liposomal T4N5 lotionDRUG

Eligibility Criteria

Age2 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Quality Research Group

Miami Beach, Florida, 33140, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

University of Minnesota Medical School

Minneapolis, Minnesota, 55455, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11790-9832, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Office of Gerald Bernstein

Seattle, Washington, 98107, United States

Location

Medizinische Klinik

Munich (Muenchen), D-80336, Germany

Location

Guy's, King's and St. Thomas' Hospitals Trust

London, England, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Precancerous ConditionsKeratosis, Actinic

Interventions

Deoxyribonuclease (Pyrimidine Dimer)

Condition Hierarchy (Ancestors)

NeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EndodeoxyribonucleasesDeoxyribonucleasesEsterasesHydrolasesEnzymesEnzymes and Coenzymes

Study Officials

  • Daniel B. Yarosh, PhD

    Applied Genetics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 2, 2004

Study Start

July 1, 1996

Last Updated

November 6, 2013

Record last verified: 2007-05

Locations

GB(1)US(7)DE(1)