Treatment of skin cancer using ablative fractional laser and ingenol mebutate.

Phase 1

Conditions: Safety and local skin reactions in patients with basal cell carcinoma after combined treatment of blative fractional laser and ingenol mebutate.
MedDRA version: 20.0Level: PTClassification code 10004146Term: Basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2017-002843-14-DK

Lead Sponsor: Bispebjerg Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients with histologically verified, lwo-risk previously untreated superficial or nodular BCCs
>18 years old
Legally competent, able to give verbal and written consent
Subejcts in good general Health, who is willing to participate and able to give informed consent and can comply with protocol requirements
Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

High risk BCC
Medical history of Gorlin syndrome or immunosuprresive medication
Known allergy to Picato or carboxy fluorescein
History of keloids
Lactating or pregnant women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1) to investigate local skin reactions and safety of ablative fractional laser (AFXL)-assisted ingenol mebutate treatment of basal cell carcinoma (BCC);Secondary Objective: 1) to monitor tumor size, clearance and reduction clinically, by non-invasive imaging techniques and histologically.<br>2) to investigate the uptake and bio-distribution of a contras-enhancer (carboxy fluorescein (CaF)) in BCC, using CaF as a surrogate for uptake and bio-distribution of IM in AFXL-exposed BCC.;Primary end point(s): 1) Local skin reactions<br>2) Safety<br>- prolonged edema <br>- blistering<br>- infection<br>-hyperpigmentation<br>-hypopigmentation<br>-scarring;Timepoint(s) of evaluation of this end point: Baseline, Day 1,3,8,15,29 and 90

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Tumor size, clearance and reduction<br>2) CaF uptake and bio-distribution in AFXL exposed BCC;Timepoint(s) of evaluation of this end point: 1) Baseline, Day 29 and 90<br>2) Baseline, Day 1