NCT00049959

Brief Summary

The purpose of the two studies is to determine whether an experimental therapy using a photoactive drug, verteporfin, in combination with direct light exposure of basal cell carcinoma of the skin can safely eliminate these skin tumors.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

First QC Date

November 15, 2002

Last Update Submit

March 1, 2011

Conditions

Basal Cell CarcinomaNevoid Basal Cell Carcinoma SyndromeGorlin Syndrome

Keywords

Verteporfin PDTmultiple basal cell carcinomanevoid basal cell carcinoma syndrome

Interventions

verteporfin PDTDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently has at least 3 eligible BCC skin tumors that have never been treated
  • Is willing to have these tumor sites surgically removed

You may not qualify if:

  • Has xeroderma pigmentosum
  • Has BCC tumors that are the result of prior radiotherapy or immunosuppression due to an organ transplant
  • Is immunosuppressed
  • Has abnormal liver function
  • Is receiving systemic chemotherapy or has received chemotherapy within the last two years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Basal CellBasal Cell Nevus SyndromeBasal cell carcinoma, multiple

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellOdontogenic CystsJaw CystsBone CystsCystsNeoplastic Syndromes, HereditaryBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesJaw DiseasesStomatognathic DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • Herma Neyndorff

    QLT Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 15, 2002

First Posted

November 19, 2002

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

March 16, 2011

Record last verified: 2011-03