Ingenol Mebutate Gel 0.05% in Kidney Transplant Recipients With Actinic Keratoses

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The substance ingenol mebutate (IM) is registered in Switzerland and many countries worldwide for the treatment of actinic keratosis (AK). There is no data on the use of IM in organ transplant recipients, a population highly affected by AK and skin cancer at large. The investigators want to study the use of IM against AK in this high-risk group of patients and assess its safety. The investigators are hoping to prove that IM is safe to use in AK of organ transplant recipients, allowing its use in the clinical routine treatement of AK also in this subset of patients with AK.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Günther Hofbauer

Criteria

Inclusion Criteria:

• Male subjects 18 years of age or older

• Female subjects 18 years of age or older of non-child bearing potential defined by a serum follicle stimulating hormone (FSH) level ≥ 25.8 mIU/ml or by a confirmed clinical history of sterility (e.g. hysterectomy)

• Renal transplantation performed two years or more before inclusion

• Stable renal transplant function as determined by physician

• Actinic keratosis, one or multiple, of the trunk and/or extremities, non-hypertrophic non-hyperkeratotic based on clinical judgment within an area of 100 cm2 total (several areas adding up to 100 cm2 permissible)

• Signed Informed Consent after oral and written explanation of the study protocol

Exclusion Criteria:

• contraindications on ethical grounds such as inability to give informed consent

• women of child-bearing potential, women who are pregnant or breast feeding

• other clinically significant concomitant disease (e.g. hepatic dysfunction, cardiovascular disease, etc) at the investigator's discretion

• known or suspected non-compliance, drug or alcohol abuse

• enrolment into a clinical trial within last 4 weeks

• prior treatment with ingenol mebutate gel

• prior local/topical treatments in the treatment area within 2 weeks of trial entry:

• Dermabrasion, chemical peeling, laser treatment, cryotherapy or surgery

• Imiquimod, diclofenac, 5-Fluorouracil (5-FU), topical corticosteroids, topical retinoids, treatment with ultraviolet B (UVB) or photodynamic treatment (PDT)