- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03569345
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Copenhagen, Denmark, 2400
- Department of Dermtology, Bispebjerg University Hospital, Copenhagen, Denmark
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in occurrence of local skin reactions
Time Frame: 0-90 days
|
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
|
0-90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response clinically
Time Frame: baseline, day 29, day 90
|
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.
|
baseline, day 29, day 90
|
Tumor response by imaging techniques
Time Frame: baseline, day 29, day 90
|
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.
|
baseline, day 29, day 90
|
Tumor response - histology
Time Frame: At day 90
|
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.
|
At day 90
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EudraCT-nr: 2017-002843-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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