Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in Situ

NAUnknownINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

January 31, 2020

Study Completion Date

January 31, 2020

Conditions
Squamous Cell Carcinoma
Interventions
DRUG

Levulan Kerastick

Intervention group subjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours.

DEVICE

blue light source

At the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals).

OTHER

participant satisfaction survey

Participants will be asked to fill out a satisfaction survey.

Sponsors
All Listed Sponsors
collaborator

DUSA Pharmaceuticals, Inc.

INDUSTRY

lead

Rhode Island Hospital

OTHER

NCT03025724 - Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in Situ | Biotech Hunter | Biotech Hunter