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Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate

Primary Purpose

Carcinoma, Basal Cell

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
AFXl-assisted ingenol mebutate delivery
Sponsored by
Merete Haedersdal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Basal Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Dermtology, Bispebjerg University Hospital, Copenhagen, Denmark

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm

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)

Outcomes

Primary Outcome Measures

Change in occurrence of local skin reactions
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 Outcome Measures

Tumor response clinically
Tumor clearance (yes or no) will be evaluated clinically at baseline, at day 29 and day 90. If residual tumor is identified at day 90 patients will receive conventional treatment according to national guidelines.
Tumor response by imaging techniques
Clearance (yes or no) will be evaluated using non-invasive reflectance confocal microscopy and optical coherence tomography at baseline, day 30 and day 90.f residual tumor is identified at day 90 patients will receive conventional treatment according to national guidelines.
Tumor response - histology
HIstological verification of tumor clearance will be performed at day 90 after first treatment using tissue sections from a punch biopsy (up to 4 mm). If residual tumor is identified at day 90 patients will receive conventional treatment according to national guidelines.

Full Information

First Posted
June 15, 2018
Last Updated
July 7, 2018
Sponsor
Merete Haedersdal
Collaborators
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03569345
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
May 18, 2018 (Actual)
Study Completion Date
May 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Merete Haedersdal
Collaborators
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Basal Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm
Arm Type
Experimental
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)
Intervention Type
Drug
Intervention Name(s)
AFXl-assisted ingenol mebutate delivery
Intervention 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 Measure Information:
Title
Change in occurrence of local skin reactions
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
Time Frame
0-90 days
Secondary Outcome Measure Information:
Title
Tumor response clinically
Description
Tumor clearance (yes or no) will be evaluated clinically at baseline, at day 29 and day 90. If residual tumor is identified at day 90 patients will receive conventional treatment according to national guidelines.
Time Frame
baseline, day 29, day 90
Title
Tumor response by imaging techniques
Description
Clearance (yes or no) will be evaluated using non-invasive reflectance confocal microscopy and optical coherence tomography at baseline, day 30 and day 90.f residual tumor is identified at day 90 patients will receive conventional treatment according to national guidelines.
Time Frame
baseline, day 29, day 90
Title
Tumor response - histology
Description
HIstological verification of tumor clearance will be performed at day 90 after first treatment using tissue sections from a punch biopsy (up to 4 mm). If residual tumor is identified at day 90 patients will receive conventional treatment according to national guidelines.
Time Frame
At day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Dermtology, Bispebjerg University Hospital, Copenhagen, Denmark
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate

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