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

Primary Purpose

Actinic Keratosis, Warts, Basal Cell Carcinoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Photodynamic therapy with Metvix 160 mg/g cream

About this trial

This is an interventional prevention trial for Actinic Keratosis focused on measuring Non-melanoma skin cancer, Organ transplant recipients, Photodynamic therapy, Actinic keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Dermatolgy, Roskilde Amtsygehus
Department of Dermatology, Århus Amysygehus
Klinik für Dermatologie, Venerologie und Allergologie, Campus Charité Mitte
Hautklinik Linden
Department of Dermatology, Rikshospitalet
Department of Dermatology, St. Olavs Hospital
Department of Dermatology, Sahlgrenska University Hospital
Department of Dermatology, Karolinska University Hospital, Huddinge
Department of Dermatology, Uppsala University Hospital
Dermatology Department, Manchester Royal Infirmary
Portsmouth Dermatology Centre, St Mary's Hospital

Outcomes

Primary Outcome Measures

To Compare occurrence of new lesions (AK, BCC, SCC and warts) in the treated area with the contralateral control area (symmetrically).

Compare number of AK lesions that show complete response in the treated area with the contralateral control area.

Secondary Outcome Measures

Compare number of BCC lesions that show complete response in the treated area with the contralateral control area.

Compare number of recurrent lesions in treated area with the contralateral control area

Assess the cosmetic outcome.

Investigate product safety in this patient population

Full Information

NCT ID

NCT00472459

First Posted

May 10, 2007

Last Updated

February 16, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT00472459

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

July 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis, Warts, Basal Cell Carcinoma, Bowens Disease, Squamous Cell Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Photodynamic therapy with Metvix 160 mg/g cream

Primary Outcome Measure Information:

Title

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

Title

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 Measure Information:

Title

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

Title

Compare number of recurrent lesions in treated area with the contralateral control area

Time Frame

9, 15, 21 and 27 months after first treatment

Title

Assess the cosmetic outcome.

Time Frame

3, 9, 15, 21 and 17 months after first treatment

Title

Investigate product safety in this patient population

Time Frame

3, 9, 15, 21 and 27 months after first treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ann-Marie Wennberg, MD, PhD

Organizational Affiliation

Sahlgrenska University Hospital, Gothenburg, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatolgy, Roskilde Amtsygehus

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Facility Name

Department of Dermatology, Århus Amysygehus

City

Århus

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Klinik für Dermatologie, Venerologie und Allergologie, Campus Charité Mitte

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Hautklinik Linden

City

Hannover

ZIP/Postal Code

30449

Country

Germany

Facility Name

Department of Dermatology, Rikshospitalet

City

Oslo

ZIP/Postal Code

0027

Country

Norway

Facility Name

Department of Dermatology, St. Olavs Hospital

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Department of Dermatology, Sahlgrenska University Hospital

City

Gothenburg

ZIP/Postal Code

41345

Country

Sweden

Facility Name

Department of Dermatology, Karolinska University Hospital, Huddinge

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

Facility Name

Department of Dermatology, Uppsala University Hospital

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

Facility Name

Dermatology Department, Manchester Royal Infirmary

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Portsmouth Dermatology Centre, St Mary's Hospital

City

Portsmouth

ZIP/Postal Code

PO3 6AD

Country

United Kingdom

12. IPD Sharing Statement

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

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