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

Completed · Phase 2

Conditions studied: BCC, BCC - Basal Cell Carcinoma, Basal Cell Carcinoma, Basal Cell Cancer, Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT04552990

Run by

Memorial Sloan Kettering Cancer Center

People needed

16

Starts

2020-09-09

Expected to finish

2025-04-04

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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(s) or nodular BCC(s) < 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(s) (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(s)

You may not qualify if…

• Subjects meeting any one of the following criteria are not eligible to participate in this study
• High-risk BCC(s) (H area, >1 cm in M area, or >2 cm in L area)
• BCC(s) 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.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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