NCT03569345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

June 15, 2018

Last Update Submit

July 7, 2018

Conditions

Carcinoma, Basal Cell

Outcome Measures

Primary Outcomes (1)

  • 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

    0-90 days

Secondary Outcomes (3)

  • Tumor response clinically

    baseline, day 29, day 90

  • Tumor response by imaging techniques

    baseline, day 29, day 90

  • Tumor response - histology

    At day 90

Study Arms (1)

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)

Drug: AFXl-assisted ingenol mebutate delivery

Interventions

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.

Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermtology, Bispebjerg University Hospital, Copenhagen, Denmark

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Senior Consultant, PhD, DMSc

Study Record Dates

First Submitted

June 15, 2018

First Posted

June 26, 2018

Study Start

November 17, 2017

Primary Completion

May 18, 2018

Study Completion

May 18, 2018

Last Updated

July 10, 2018

Record last verified: 2018-07

Locations

DK(1)