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

Spirig Pharma

Status and phase: Terminated; Phase 3

Conditions: Actinic Keratoses; Squamous Cell Carcinomas

Treatments: Other: Standard Sun Protection Measures; Device: MD-3511356

Study type: Interventional

Funder types: Industry

Identifiers

NCT01532453

SP 488/2009

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 244 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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244 participants in 2 patient groups

Standard Sun Protection Measures

Active Comparator group

Description:

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).

Treatment:

Other: Standard Sun Protection Measures

MD-3511356

Experimental group

Description:

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).

Treatment:

Device: MD-3511356