A Multi-center, Open-label, Uncontrolled, Investigator-initiated Trial to Evaluate the Safety and Efficacy of Ingenol Mebutate Gel 0.05% in Kidney Transplant Recipients With Actinic Keratoses on the Trunk and Extremities
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Günther Hofbauer
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Safety (Change in creatinine from baseline)
Study Overview
Brief 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.
Detailed Description
Ingenol mebutate gel, 0.05%, commercially supplied in a box of 2 single use, unit dose tubes for topical application for each 25cm2, four conjunctive 25cm2 areas (100cm2) will be treated. If the 100 cm2 area is not cleared at Day 57 (+/- 3 Days), a second treatment cycle will be initiated with commercially supplied drug in a box of 2 single use, unit dose tubes for topical application for each 25cm2 and four conjunctive 25cm2 areas (100cm2 ) will be treated. In total for the first cycle, 4 commercially supplied boxes (8 unit dose tubes) will be used, and for the second cycle an additional 4 commercially supplied boxes (8 unit dose tubes) will be used (in total 8 boxes, 16 unit dose tubes per patient).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Ingenol mebutate 500 ucg
active arm
Intervention: ingenol mebutate 500 ucg (Drug)
Outcomes
Primary Outcomes
Safety (Change in creatinine from baseline)
Time Frame: 24 weeks
Change in creatinine from baseline
Secondary Outcomes
- Efficacy (Reduction in actinic keratosis lesion count)(24 weeks)
Investigators
Günther Hofbauer
Senior staff physician
University of Zurich