Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate

Merete Haedersdal

Status and phase: Completed; Phase 2; Phase 1

Conditions: Carcinoma, Basal Cell

Treatments: Drug: AFXl-assisted ingenol mebutate delivery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03569345

EudraCT-nr: 2017-002843-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Arm

Experimental group

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)

Treatment:

Drug: AFXl-assisted ingenol mebutate delivery