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

NCT02473848 | Terminated Phase 3

• 1 other identifier: KEKZH2013-0525
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Safety (Change in creatinine from baseline)

  Change in creatinine from baseline

  24 weeks

Secondary Outcomes (1)

• Efficacy (Reduction in actinic keratosis lesion count)

  24 weeks

Study Arms (1)

Ingenol mebutate 500 ucg

EXPERIMENTAL

active arm

Drug: ingenol mebutate 500 ucg

Interventions

ingenol mebutate 500 ucg DRUG

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).

Also known as: Picato 500 ucg

Ingenol mebutate 500 ucg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Günther Hofbauer: lead

Study Sites (1)

Dermatology Department University Hospital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Günther FL Hofbauer, MD

  Dermatology Department University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior staff physician

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 17, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

CH (1)