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

Actinic Keratosis Clinical Trial

— IMOT001  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02473848
• Other study ID #: KEKZH2013-0525
• Status: Terminated
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• ingenol mebutate 500 ucg
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).

Locations

Country	Name	City	State
Switzerland	Dermatology Department University Hospital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Günther Hofbauer

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Change in creatinine from baseline)	Change in creatinine from baseline	24 weeks
Secondary	Efficacy (Reduction in actinic keratosis lesion count)	Reduction in actinic keratosis lesion count	24 weeks