Basal Cell Carcinoma Clinical Trial
Official title:
Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma
Verified date | May 2024 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 16 |
Est. completion date | September 9, 2024 |
Est. primary completion date | September 9, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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(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) Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical evaluation of local skin responses on Day 0 | Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 0 (PDT treatment #1) | Day 1 | |
Primary | Clinical evaluation of local skin responses on Day 3 | Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 3 | Day 3 | |
Primary | Clinical evaluation of local skin responses on Day 14 | Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 14 (PDT treatment #2) | Day 14 | |
Primary | Clinical evaluation of local skin responses on Day 17 | Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 17 | Day 17 | |
Primary | Clinical evaluation of local skin responses 3 months post treatment | Clinical evaluation of local skin responses on a 0-4 point scale will be performed 3 months post treatment | 3 months after treatment |
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