Clinical trial NCT03569345: Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Basal Cell
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: LEO Pharma
First posted: 2018-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Patients will receive ablative fractional laser (AFXl)-assisted ingenol mebutate (IM) as a treatment for their cutaneous basal cell carcinoma (BCC). Treatment areas consisting of tumors and a 5 mm margin will undergo AFXl exposure (CO2 laser) followed by IM 0.015% or 0.05% under occlusion for 2-3 days. .

local skin reactions are monitored at baseline (day1), day 3/4, day 8, day 15, day 29, day 90, and tumor response monitored at baseline, day 29, and day 90. An additional repeat AFXl-IM treatment on day 29 will be offered if tumors persist, based on clinical evaluation and imaging on day 30.

Primary outcome:

1. severity and duration of clinical local skin reactions including erythema, scaling, edema, blistering, erosion/ulceration and crusting using a 0-4-point scale at all visits from baseline to day 90.
2. To monitor BCC tumor response on clinical assessments supported by non-invasive imaging techniques including optical coherence tomography (OCT) and reflectance confocal microscopy (RCM) at baseline, day 29 and day 90.

Eligibility criteria: 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

Primary outcomes:
measure: Change in occurrence of local skin reactions
timeFrame: 0-90 days
Secondary outcomes:
measure: Tumor response clinically
timeFrame: baseline, day 29, day 90
measure: Tumor response by imaging techniques
timeFrame: baseline, day 29, day 90
measure: Tumor response - histology
timeFrame: At day 90
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Dermtology, Bispebjerg University Hospital, Copenhagen, Denmark
Study officials:
References: