Carcinoma, Basal CellPhase 1/2NCT03569345
Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate
A Phase 1/2 study testing AFXl-assisted ingenol mebutate delivery in people with Carcinoma, Basal Cell, run by Merete Haedersdal at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Basal Cell
- What is being tested?
- AFXl-assisted ingenol mebutate delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Nov 2017to 18 May 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Department of Dermtology, Bispebjerg University Hospital, Copenhagen, Denmark
Copenhagen, 2400
About this study
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.
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.
Read the 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.
- Conditions
- Carcinoma, Basal Cell
- Being tested
- AFXl-assisted ingenol mebutate delivery
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFXl-assisted ingenol mebutate deliveryDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm | Experimental | 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) Receives: Drug: AFXl-assisted ingenol mebutate delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-90 days
Secondary outcomes (3)
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.
Measured: baseline, day 29, day 90
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.
Measured: baseline, day 29, day 90
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.
Measured: At day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start17 Nov 2017
- Primary completion18 May 2018
- Study completion18 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Basal CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merete Haedersdal
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor-investigator, Merete Haedersdal, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569345
- Sponsor's protocol ID
- EudraCT-nr: 2017-002843-14
- Status last verified
- Jul 2018
- First submitted
- 15 Jun 2018
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03569345
- Acronym / sponsor ID
- EudraCT-nr: 2017-002843-14
- Conditions
- Carcinoma, Basal Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merete HaedersdalUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 18 May 2018 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm | Experimental | Drug: AFXl-assisted ingenol mebutate deliveryBasal 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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:
- ii. Size:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFXl-assisted ingenol mebutate deliveryPatients 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. | Drug | Arm |
Primary outcome
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
3 secondary outcomes
Tumor response clinically
Time frame: baseline, day 29, day 90
Tumor response by imaging techniques
Time frame: baseline, day 29, day 90
Tumor response - histology
Time frame: At day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AFXl-assisted ingenol mebutate delivery in people with Carcinoma, Basal Cell, run by Merete Haedersdal at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in occurrence of local skin reactions (time frame: 0-90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.