Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma

• Status: Recruiting
• Trial end date: 2022-09-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out whether injecting ALA into the skin with a jet-injection device and activating the drug with light is a safe treatment that causes few or mild side effects in people with basal cell carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Criteria

Inclusion Criteria:

Subjects who meet all of the following criteria are eligible to participate in this study

• Histologically-verified, previously untreated low-risk mixed superficial and nodular BCC or nodular BCCs < 1 cm in diameter on scalp, extremities, or trunk.

• ≥ 18 years of age

• Owner of a smartphone (Android or iPhone). Patients without a working smartphone will not be considered eligible for this study.

• Being able to download application on their phone

• Being able to take pictures of their treated BCC (with or without assistance)

• Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment. (Female subjects are considered of childbearing potential unless they have been hysterectomized or have undergone tubal ligation or have been post-menopausal for at least one year prior to the first visit)

• Legally competent, able to give verbal and written informed consent

• Subject in good general health and willing to participate comply with protocol requirements.

• Superficial and nodular BCC

Exclusion Criteria:

Subjects meeting any one of the following criteria are not eligible to participate in this study

• High-risk BCC (H area, >1 cm in M area, or >2 cm in L area)

• BCC subtype morpheaform

• Diagnosed with gorlin syndrome

• Receiving immunosuppressive medication

• Subjects with a known allergy to ALA

• Individuals with other interfering skin diseases in the area of treatment

• Subjects with a tattoo in the treatment area which may interfere with or confound the evaluation of the study

• Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator

• Lactating or pregnant women

• Patient who are taking prescription pain medications or can not stop OTC pain medications.