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Sponsored by: |
PhotoCure |
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Information provided by: | PhotoCure |
ClinicalTrials.gov Identifier: | NCT00472459 |
Patients on immunosuppressive therapy, e.g. organ recipients, have a higher occurrence of AK than the untreated population. Keratotic lesions (i.e. AK lesions and warts) in this population is highly associated with development of SCC also with 10 times higher mortality rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and BCC, increases with graft survival time and the length of immunosuppressive treatment period.
The higher risk of developing skin malignancy and more aggressive skin malignancies in this population, indicate the need for early removal of these pre-malignant lesions.
In this study, two contralateral areas (5x10 cm2) with skin lesions within the patient will be compared. One area will receive Metvix PDT at defined intervals and the other will receive lesion specific treatment at the discretion of the investigator. The primary end-point will be the accumulated number of new lesions during the study and number of AK lesions that show complete response 3 months after baseline. Secondary endpoints will be number of BCC lesions that show complete response, number of recurrent lesions, assessment of cosmetic outcome and safety.
Condition | Intervention | Phase |
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Actinic Keratosis Warts Basal Cell Carcinoma Bowens Disease Squamous Cell Carcinoma |
Procedure: Photodynamic therapy with Metvix 160 mg/g cream |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre, Randomised Study of Photodynamic Therapy(PDT) With Metvix® 160 mg/g Cream in Immuno-Compromised Patients With Non-Melanoma Skin Cancer |
Enrollment: | 81 |
Study Start Date: | July 2003 |
Study Completion Date: | July 2006 |
The treatment area (5x10 cm2) will be treated at baseline and at 3, 9 and 15 months visits. At baseline the area will be treated with fractionated Metvix® PDT treatment consisting of two treatment one week apart and at 3, 9, and 15 months visits with single Metvix® PDT treatment. The patients will be evaluated for occurrence of new lesions, lesion response and recurrence at 3 (not recurrence), 9, 15, 21 and 27 months visits. New and recurrent lesions in the treated area will be treated with Metvix® PDT treatment. Lesions with partial response in the treated area will be re-treated with Metvix® PDT and lesions with no response will be treated with lesion specific treatment at the discretion of the investigator.
In the contralateral control area (5x10 cm2), new and recurrent lesions and lesions in non-complete response will be treated with lesion specific treatment at the discretion of the investigator at each study visit.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Department of Dermatology, Århus Amysygehus | |
Århus, Denmark, 8000 | |
Department of Dermatolgy, Roskilde Amtsygehus | |
Roskilde, Denmark, 4000 | |
Germany | |
Klinik für Dermatologie, Venerologie und Allergologie, Campus Charité Mitte | |
Berlin, Germany, 10117 | |
Hautklinik Linden | |
Hannover, Germany, 30449 | |
Norway | |
Department of Dermatology, Rikshospitalet | |
Oslo, Norway, 0027 | |
Department of Dermatology, St. Olavs Hospital | |
Trondheim, Norway, 7006 | |
Sweden | |
Department of Dermatology, Sahlgrenska University Hospital | |
Gothenburg, Sweden, 41345 | |
Department of Dermatology, Karolinska University Hospital, Huddinge | |
Stockholm, Sweden, 14186 | |
Department of Dermatology, Uppsala University Hospital | |
Uppsala, Sweden, 75185 | |
United Kingdom | |
Portsmouth Dermatology Centre, St Mary's Hospital | |
Portsmouth, United Kingdom, PO3 6AD | |
Dermatology Department, Manchester Royal Infirmary | |
Manchester, United Kingdom, M13 9WL |
Principal Investigator: | Ann-Marie Wennberg, MD, PhD | Sahlgrenska University Hospital, Gothenburg, Sweden |
Study ID Numbers: | PC T313/03 |
Study First Received: | May 10, 2007 |
Last Updated: | May 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00472459 |
Health Authority: | Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Denmark: Danish Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Non-melanoma skin cancer Organ transplant recipients Photodynamic therapy Actinic keratosis |
Keratosis Carcinoma, Basosquamous Skin Diseases Squamous cell carcinoma Methyl 5-aminolevulinate Carcinoma, Basal Cell Skin Neoplasms Aminolevulinic Acid Carcinoma |
Epidermoid carcinoma Bowen's Disease Warts Bowen's disease Carcinoma, squamous cell Neoplasms, Squamous Cell Carcinoma, Squamous Cell Tylosis Neoplasms, Glandular and Epithelial |
Photosensitizing Agents Neoplasms Neoplasms by Site Neoplasms by Histologic Type Radiation-Sensitizing Agents |
Therapeutic Uses Physiological Effects of Drugs Neoplasms, Basal Cell Dermatologic Agents Pharmacologic Actions |