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

Investigations of local skin reactions and safety after combined treatment of basal cell carcinoma using ablative fractional laser and ingenol mebutate - an exloratory, prospective, open-label phase 2a trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002843-14-DK

Enrollment

Registered

2017-07-21

Start date

2017-09-26

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety and local skin reactions in patients with basal cell carcinoma after combined treatment of blative fractional laser and ingenol mebutate. MedDRA version: 20.0 Level: PT Classification code 10004146 Term: Basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Picato (ingenol mebutate) Product Name: Picato Product Code: D06BX02 Pharmaceutical Form: Gel INN or Proposed INN: PICATO CAS Number: 75567-37-2 Current Sponsor code: PEP005 D06BX02 Other

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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 2) Safety - prolonged edema - blistering - infection -hyperpigmentation -hypopigmentation -scarring;Timepoint(s) of evaluation of this end point: Baseline, Day 1,3,8,15,29 and 90	—

Measure

Time frame

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. 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 2) Safety - prolonged edema - blistering - infection -hyperpigmentation -hypopigmentation -scarring;Timepoint(s) of evaluation of this end point: Baseline, Day 1,3,8,15,29 and 90

—

Secondary

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

Countries

Denmark

Contacts

Public ContactDermatologisk Afdeling

Bispebjerg hospital

mhaedersdal@dadlnet.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026