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

NCT01532453 | Terminated Phase 3 Results DMC

• 1 other identifier: SP 488/2009
• Study Type: interventional
• Target: 244
• Locations: 9 countries
• Sites: 10

Brief Summary

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.

Conditions

Actinic Keratoses; Squamous Cell Carcinomas

Outcome Measures

Primary Outcomes (1)

• Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas

  2 Years

Secondary Outcomes (1)

• Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas

  2 Years

Study Arms (2)

Standard Sun Protection Measures

ACTIVE COMPARATOR

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).

Other: Standard Sun Protection Measures

MD-3511356

EXPERIMENTAL

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).

Device: MD-3511356

Interventions

MD-3511356 DEVICE

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

MD-3511356

Standard Sun Protection Measures OTHER

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

Standard Sun Protection Measures

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spirig Pharma Ltd.: lead

Study Sites (10)

Medizinische Universität Wien

Vienna, Austria

Location

Charles University Hospital

Pilsen, Czechia

Location

Hôpital Edouard

Lyon, France

Location

Klinikum der Charité Universitätsmedizin

Berlin, 10117, Germany

Location

Hautklinik am Nationalen Zentrum für Tumorerkrankungen

Heidelberg, Germany

Location

Beaumont Hospital

Dublin, Ireland

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Universitätsspital Zürich, Dermatologische Klinik

Zurich, Switzerland

Location

Başkent University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

Queen Mary University of London

London, United Kingdom

Location

MeSH Terms

Conditions

Keratosis, Actinic; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Limitations and Caveats

Trial was terminated early for futility reasons (outcome would not be changed, if trial pursued up completion) and potential "loss of chance" (which could neither be confirmed nor rejected at the time) for patients included in the MD 3511356 group.

Results Point of Contact

• Title: Dr. Francine Santoro
• Organization: Galderma Spirig

Francine.santoro@galderma.com

+41 62 387 87 87

Study Officials

• Claas Ulrich, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 14, 2012
• Study Start: November 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 8, 2016
• Results First Posted: January 8, 2016

Record last verified: 2015-12

Locations

TU (1); NL (1); AU (1); DE (2); FR (1); GB (1); CZ (1); IE (1); CH (1)