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An Open, Multicentre, Randomised, Inter-individual Comparative, Prospective Clinical Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Outpatients After Solid Organ Transplantations for the Prevention of UV-induced Infections and Carcinogenic Skin Alterations.


Phase 3
40 Years
N/A
Open (Enrolling)
Both
Actinic Keratoses, Squamous Cell Carcinomas

Thank you

Trial Information

An Open, Multicentre, Randomised, Inter-individual Comparative, Prospective Clinical Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Outpatients After Solid Organ Transplantations for the Prevention of UV-induced Infections and Carcinogenic Skin Alterations.


Inclusion Criteria:



- Out-Patients of either sex aged ≥ 40 years

- Life-expectancy of 2 years at minimum

- Solid organ-transplant recipients who received a kidney (including pancreas), liver,
lung, or heart transplant

- Patients treated for 5 years with an immunosuppressant medication

- Severe sun damage of the skin

- Multiple actinic keratoses (2-5 lesions) and/or multiple dysplastic naevi

- No present squamous cell carcinoma, basal cell carcinoma or malignant melanoma; but
history of cutaneous/cutaneous invasive malignancy with restitutio ad integrum is
allowed

- Patients who are able to understand and provide written informed consent to
participate in the clinical trial (signed informed consent) according to ICH GCP

Exclusion Criteria:

- Non-Caucasian

- Absence of sun damage i.e. no signs of AK

- Multi-organ transplantation (exception: simultaneous transplantation of kidney and
pancreas)

- Evidence of systemic infection, except viral hepatitis, at the time of recruitment

- Known or supposed systemic malignant tumour or systemic chemotherapy within the last
5 years prior to randomisation

- Patients participating in a clinical trial within the last four weeks before trial

- Patients treated with the antitumour/antiangiogenetic immunosuppressant sirolimus,
respectively everolimus, or acitretin or any other systemic treatment for AK at the
time of randomisation

- Patients treated with a topical drug for the AK at the time of randomisation
(exception: excision or kryotherapy for hyperkeratotic lesions are allowed)

- Change of the immunosuppression-treatment less than 3 months ago or planned

- Present or planned interferon therapy (in liver transplant patients with hepatitis
B/C)

- Female patients with childbearing potential with a positive pregnancy test, breast
feeding, or female patients with childbearing potential without adequate
contraception

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of new clinically diagnosed actinic keratoses or squamous cell carcinomas

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

Claas Ulrich, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinikum der Charité Universitätsmedizin, Hauttumorzentrum Charité, D-10117 Berlin/Germany

Authority:

Switzerland: Ethikkommission

Study ID:

SP 488/2009

NCT ID:

NCT01532453

Start Date:

November 2010

Completion Date:

June 2015

Related Keywords:

  • Actinic Keratoses
  • Squamous Cell Carcinomas
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Keratosis
  • Keratosis, Actinic
  • Infection

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