Trial record 4 of 8 for:    "oculodentodigital dysplasia"

Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.

This study has been terminated.
Information provided by:
QLT Inc. Identifier:
First received: November 15, 2002
Last updated: March 1, 2011
Last verified: March 2011
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.

Condition Intervention Phase
Basal Cell Carcinoma
Nevoid Basal Cell Carcinoma Syndrome
Gorlin Syndrome
Drug: verteporfin PDT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Masked, Multicenter Phase III Study Of Photodynamic Therapy With Verteporfin For Injection (VFI) For The Treatment Of Multiple Basal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by QLT Inc.:

Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Detailed Description:

Basal cell carcinoma (BCC) of the skin is the most common type of cancer that can be treated with various therapies including surgical removal. A number of factors can lead to the development of multiple BCC of the skin, including genetic disorders (e.g., nevoid basal cell carcinoma syndrome). Treatment of multiple BCC becomes much more challenging. In these trials, the experimental therapy: verteporfin PDT is compared to placebo PDT. PDT or photodynamic therapy in these studies is the combination of the photoactive drug verteporfin (given intravenously) and red light exposure of skin tumors.

The primary objective is to assess whether verteporfin PDT can completely eliminate multiple BCCs. Eligible subjects will have at least 3 BCCs. Study subjects won't know which treatment they have been been assigned to - this is done randomly (like flipping a coin). After study treatment, the BCCs in each subject will be closely observed and toward the end of the study all will be surgically removed and examined to verify response to study treatment. Safety will be assessed by testing blood samples before and after study treatment, and analyzing adverse events and skin reactions to the study treatment.


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00049959

Sponsors and Collaborators
QLT Inc.
Study Director: Herma Neyndorff QLT Inc.
  More Information

Additional Information:
No publications provided Identifier: NCT00049959     History of Changes
Other Study ID Numbers: VFI MBCC 01 and VFI MBCC 02 
Study First Received: November 15, 2002
Last Updated: March 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by QLT Inc.:
Verteporfin PDT
multiple basal cell carcinoma
nevoid basal cell carcinoma syndrome

Additional relevant MeSH terms:
Basal Cell Nevus Syndrome
Carcinoma, Basal Cell
Focal Dermal Hypoplasia
Hamartoma Syndrome, Multiple
Abnormalities, Multiple
Bone Cysts
Bone Diseases
Bone Diseases, Developmental
Congenital Abnormalities
Ectodermal Dysplasia
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Jaw Cysts
Jaw Diseases
Musculoskeletal Diseases
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Odontogenic Cysts
Pathologic Processes
Skin Abnormalities processed this record on February 11, 2016