Photodynamic Therapy to Treat Actinic Damage in Patients With Squamous Cell Carcinoma (SCC) of the Lip

PHASE4CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

July 31, 2010

Study Completion Date

September 30, 2010

Conditions
Actinic CheilitisSquamous Cell Carcinoma In-situ (SCC-is)Squamous Cell Carcinoma (SCC)Photodynamic Therapy (PDT)Mohs Surgery
Interventions
PROCEDURE

PDT prior to Mohs surgery

"Day 1: Screening and consent for this study. If eligible, a scouting biopsy will be obtained at 1 cm from the clinical border of the SCC for confirmation of AC.~7-14 Days after consultation: PDT to all subjects in the study. If during treatment a subject requests to discontinue due to pain the treatment will be terminated.~3-5 weeks after consultation: return for assessment. At this visit, the assigned treatment may be repeated if the treatment site is adequately healed. Re-treatment will only occur if there is persistent actinic damage.~6-8 weeks after consultation: Mohs surgery will be performed as per routine. Following tumor removal a scouting biopsy will be taken at a site 1 cm from the wound site created by SCC removal. The current waiting time for non-urgent surgery is 8 weeks. Standard care is not being altered for subjects in the study, other then their receiving the PDT intervention.~Photographs may be taken at each subject visit."

Trial Locations (1)

02111

Tufts Medical Center, Department of Dermatology, Boston

Sponsors
All Listed Sponsors
collaborator

DUSA Pharmaceuticals, Inc.

INDUSTRY

lead

Tufts Medical Center

OTHER