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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02473848
Other study ID # KEKZH2013-0525
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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