Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-01-31

Brief Summary

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The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.

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Detailed Description

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This open-label multicenter, randomized, inter-individual comparative, prospective clinical trial was designed to evaluate the efficacy and safety of MD 3511356 sunscreen in preventing AK and SCC in post transplant immune-suppressed patients compared to standard of care.

The present multicenter trial is intended to contribute to the evidence that daily sun protection will have a prophylactic effect in this high risk population of chronically immune compromised patients.

Conditions

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Actinic Keratoses Squamous Cell Carcinomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard Sun Protection Measures

Detailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget).

Group Type ACTIVE_COMPARATOR

Standard Sun Protection Measures

Intervention Type OTHER

Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.

MD-3511356

Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g).

Group Type EXPERIMENTAL

MD-3511356

Intervention Type DEVICE

Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.

Interventions

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MD-3511356

Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.

Intervention Type DEVICE

Standard Sun Protection Measures

Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.

Intervention Type OTHER

Eligibility Criteria

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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 Cryotherapy 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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No