Clinical trial · Interventional
Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma
NCT04552990CI-TRIAL-00115171completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Cancer | Skin Basal Cell Carcinoma | ALIAS | 0.90 |
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| BCC | Skin Basal Cell Carcinoma | ALIAS | 0.90 |
| BCC - Basal Cell Carcinoma | Basal Cell Neoplasm | PROBABILISTIC | 0.70 |
| Nodular Basal Cell Carcinoma | Skin Nodular Basal Cell Carcinoma | ALIAS | 0.90 |
| Superficial Basal Cell Carcinoma | Superficial Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Illumination | Procedure | — | UNRESOLVED |
| Incubation | Other | — | UNRESOLVED |
| Jet injection of ALA | Drug | — | UNRESOLVED |
| Surgical excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tumor Excision, No Illumination
- description
- The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy.
- interventionNames
- Drug: Jet injection of ALA
- Procedure: Surgical excision
- Other: Incubation
- type
- EXPERIMENTAL
- label
- PDT treatment with jet-injections
- description
- Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks.
- interventionNames
- Drug: Jet injection of ALA
- Procedure: Surgical excision
- Procedure: Illumination
- Other: Incubation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.