Clinical trial · Interventional
Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate
Investigation of Local Skin Reactions and Safety After Combined Treatment of Basal Cell Carcinoma Using Ablative Fractional Laser and Ingenol Mebutate - an Exploratory, Prospective, Open-label Phase 2a Trial.
NCT03569345CI-TRIAL-00033689completedPhase 1 / Phase 2ClinicalTrials.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)
A prospective clinical, uncontrolled, open-label, explorative phase 2a trial on patients with histologically-confirmed superficial and nodular basal cell carcinoma (BCC). The study assesses tolerability and tumor clearance after laser-assisted topical delivery of topical ingenol mebutate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Basal Cell | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AFXl-assisted ingenol mebutate delivery | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm
- description
- Basal cell carcinoma (BCC) patients Patients (\>18 pr) with histologically-verified superficial or nodular basal cell carcinoma (\<20 mm on face/scalp, \<50 mm on trunk/extremities)
- interventionNames
- Drug: AFXl-assisted ingenol mebutate delivery
Primary outcomes (1)
- measure
- Change in occurrence of local skin reactions
- timeFrame
- 0-90 days
- description
- Non-blinded, clinical evaluation of local erythema, edema, flaking, crusting/scabbing, pustulation, scarring, hypo(hyperpigmentation, infection in treated areas will be performed by physician using an FDA-approved 0-4 point lsr scale at day 1, 3/4, 8, 15, 29 and 90 after AFXl exposure. Standardized, clinical photographs are taken to document skin reactions at each visit
Secondary outcomes (3)
- measure
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 * Patients with histologically verified, low-risk, previously untreated superficial or nodular BCCs on the scalp, face, extremities or trunk * \> 18 years of age at baseline * Legally competent, able to give verbal and written consent * Communicate in Danish verbally as well as in writing * Subject in good general health, is willing to participate and able to give informed consent, and can comply with protocol requirements. * Fitzpatrick skin phototype I-III * Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment. Exclusion Criteria: Subjects meeting any one of the following criteria are not eligible to participate in this study * Patients with o High-risk BCC * Tumors on the following anatomical locations: * Midface region * Orbital areas * Ears * ii. Size: * \> 20 mm in facial/scalp areas * \> 50 mm in non-facial/non-scalp areas * Subtype: * Morpheaform * Medical history * Gorlin syndrome o Immunosuppressive medication * Subjects with a known allergy to IM. * Individuals with other skin diseases in the area of research interest * Subjects with tattoo in the treatment area which may interfere with or confound evaluation of the study * Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator * Subjects with Fitzpatrick skin phototype IV-VI * Lactating or pregnant women
References
Publications (0)
Data not yet available
No reference posted for this study.