Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate

NCT ID: NCT03569345

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-17
• Study Completion Date: 2018-05-18

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.

Conditions

Carcinoma, Basal Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm

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)

Group Type: EXPERIMENTAL

AFXl-assisted ingenol mebutate delivery

Intervention Type: DRUG

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.

Interventions

AFXl-assisted ingenol mebutate delivery

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: collaborator

Merete Haedersdal

OTHER

Sponsor Role: lead

Responsible Party

Merete Haedersdal

Professor, Senior Consultant, PhD, DMSc

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Dermtology, Bispebjerg University Hospital, Copenhagen, Denmark

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

EudraCT-nr: 2017-002843-14

Identifier Type: -

Identifier Source: org_study_id