Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma (NCT04552990) | Clinical Trial Compass
CompletedPhase 2
Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
United States16 participantsStarted 2020-09-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tr…
What they're measuring
1
Clinical evaluation of local skin responses on Day 0
Timeframe: Day 1
2
Clinical evaluation of local skin responses on Day 3
Timeframe: Day 3
3
Clinical evaluation of local skin responses on Day 14
Timeframe: Day 14
4
Clinical evaluation of local skin responses on Day 17
Timeframe: Day 17
5
Clinical evaluation of local skin responses 3 months post treatment