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Ingenol Mebutate Gel 0.05% in Kidney Transplant Recipients With Actinic Keratoses (IMOT001)

Primary Purpose

Actinic Keratosis

Status

Terminated

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

ingenol mebutate 500 ucg

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Dermatology Department University Hospital Zürich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ingenol mebutate 500 ucg

Arm Description

active arm

Outcomes

Primary Outcome Measures

Safety (Change in creatinine from baseline)

Change in creatinine from baseline

Secondary Outcome Measures

Efficacy (Reduction in actinic keratosis lesion count)

Reduction in actinic keratosis lesion count

Full Information

NCT ID

NCT02473848

First Posted

June 10, 2015

Last Updated

July 17, 2018

Sponsor

Günther Hofbauer

1. Study Identification

Unique Protocol Identification Number

NCT02473848

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

Lack of enrolment

Study Start Date

June 2015 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Günther Hofbauer

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ingenol mebutate 500 ucg

Arm Type

Experimental

Arm Description

active arm

Intervention Type

Drug

Intervention Name(s)

ingenol mebutate 500 ucg

Other Intervention Name(s)

Picato 500 ucg

Intervention Description

Primary Outcome Measure Information:

Title

Safety (Change in creatinine from baseline)

Description

Change in creatinine from baseline

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Efficacy (Reduction in actinic keratosis lesion count)

Description

Reduction in actinic keratosis lesion count

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Günther FL Hofbauer, MD

Organizational Affiliation

Dermatology Department University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dermatology Department University Hospital Zürich

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

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

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