Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate

• Status: Completed
• Trial end date: 2018-05-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merete Haedersdal
• Collaborator: LEO Pharma

Criteria

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