PDT With Metvix® 160 mg/g Cream in Organ Transplant Recipients With Non-melanoma Skin Cancer - Full Text View

Sponsor:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00472459

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cosmetics Skin Cancer Warts

Drug Information available for: Methyl aminolevulinate

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

To Compare occurrence of new lesions (AK, BCC, SCC and warts) in the treated area with the contralateral control area (symmetrically). [ Time Frame: 3, 9, 15, 21 and 27 months after first treatment ]
Compare number of AK lesions that show complete response in the treated area with the contralateral control area. [ Time Frame: 3, 9, 15, 21 and 27 months after first treatment ]

Secondary Outcome Measures:

Compare number of BCC lesions that show complete response in the treated area with the contralateral control area. [ Time Frame: 3, 9, 15, 21 and 27 months after first treatment ]
Compare number of recurrent lesions in treated area with the contralateral control area [ Time Frame: 9, 15, 21 and 27 months after first treatment ]
Assess the cosmetic outcome. [ Time Frame: 3, 9, 15, 21 and 17 months after first treatment ]
Investigate product safety in this patient population [ Time Frame: 3, 9, 15, 21 and 27 months after first treatment ]

Enrollment:	81
Study Start Date:	July 2003
Study Completion Date:	July 2006

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Transplant recipients with at least 2 clinically diagnosed AK lesion and maximum 10 skin lesions (AK, BCC, SCC in situ and/or warts) in each of the two contralateral areas (diameter 5x10 cm) in the face, the scalp, the extremities or on the trunk/neck.
Transplant recipients who previously are treated more than once for their skin lesions.
Transplant recipients who have received immunosuppressive therapy for more than 3 years.
Males or females above 18 years of age.
Written informed consent.

Exclusion Criteria:

Patients with more than 10 skin lesions (AK,BCC,SCC in situ,warts) in one of the two areas.
Patient with SCC (not SCC in situ) in one of the two areas.
Patients not previously treated or treated only once for their skin lesions.
Patient with rosacea in one of the two areas.
Patients with morpheaform/highly infiltrating BCC
Known allergy to methyl-aminolevulinate, a similar compound or excipients of the cream
Participation in other clinical studies either concurrently or within the last 30 days.
Pregnant or breast-feeding (all women of child-bearing potential must document a negative pregnancy test and use the pill or IUD during the treatments and for at least one month thereafter).
Conditions associated with a risk of poor protocol compliance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472459

Locations

Denmark
Department of Dermatolgy, Roskilde Amtsygehus
Roskilde, Denmark, 4000
Department of Dermatology, Århus Amysygehus
Århus, Denmark, 8000
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
Dermatology Department, Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Portsmouth Dermatology Centre, St Mary's Hospital
Portsmouth, United Kingdom, PO3 6AD

Sponsors and Collaborators

Galderma

Investigators

Principal Investigator:

Ann-Marie Wennberg, MD, PhD

Sahlgrenska University Hospital, Gothenburg, Sweden

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00472459 History of Changes
Other Study ID Numbers:	PC T313/03
Study First Received:	May 10, 2007
Last Updated:	September 1, 2010
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

Keywords provided by Galderma:

Non-melanoma skin cancer
Organ transplant recipients
Photodynamic therapy
Actinic keratosis

Additional relevant MeSH terms:

Bowen's Disease
Carcinoma
Skin Neoplasms
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Keratosis
Keratosis, Actinic
Carcinoma, Basosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

Neoplasms by Site
Skin Diseases
Neoplasms, Basal Cell
Precancerous Conditions
Methyl 5-aminolevulinate
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012