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More info
You can access this
clinical trial
if you have
Squamous Cell Carcinoma
and you are
over 18
years old
-
The phase for this study is not defined.
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The purpose

This pilot study will evaluate the effectiveness of using photodynamic therapy for treatment of cutaneous squamous cell in situ (SCCis). Our hypothesis is that PDT will be effective for treating SCCis. This study will also secondarily evaluate the tolerability of using photodynamic therapy for treatment of SCCis. Investigators plan to enroll 40 subjects with biopsy proven SCCis. Exclusion criteria include lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction to topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue light (BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of > 6 skin cancers in the past year, photosensitizing condition such as lupus, or sensitivity to porphyrins. Age, gender, size, and location of the SCCis will be recorded. All subjects will receive surgical treatment of their SCCis. The control group will undergo a surgical excision of the tumor. After the excision, subjects will be asked to fill out a satisfaction survey. The intervention group will receive PDT plus surgical treatment. Photographs of the lesion will be taken at each study visit. Subjects in the intervention group will then undergo the study procedure of application of topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. At 3-5 weeks after the initial treatment, the subject will repeat the 3-hour ALA incubation and blue light exposure. At 6 months after the last treatment, subjects in the intervention group will return for clinical follow-up and surgical excision of the lesion. After excision, the specimen will be sent for processing by pathology and subjects will be asked to fill out a satisfaction visual analog scale. All slides will be read by a board-certified dermatopathologist. Side effects will also be monitored using the same graded scale described previously. Mild adverse events that have been associated with PDT, including erythema, skin crusting, superficial blistering, hypopigmentation, and hyperpigmentation. These reactions usually occur during or immediately after the PDT treatment.

Provided treatments

  • Drug: Levulan Kerastick
  • Device: blue light source
  • Other: participant satisfaction survey

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT03025724. The sponsor of the trial is Rhode Island Hospital and it is looking for 40 volunteers for the current phase.
Official trial title:
Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in Situ