Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer

NCT00472459 | Completed Phase 3 Results

• 1 other identifier: PC T313/03
• Study Type: interventional
• Target: 82
• Locations: 5 countries
• Sites: 11

Brief Summary

Participants on immunosuppressive therapy, e.g., organ recipients, had higher occurrence of AK (Actinic Keratosis) than the untreated population. Keratotic lesions (i.e., AK lesions and warts) in this population were highly associated with development of SCC (Squamous Cell Carcinoma) also with 10 times higher mortality rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and BCC (Basal Cell Carcinoma), increased 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, indicated the need for early removal of these pre-malignant lesions. In this study, two contralateral areas (5x10 cm\^2) with skin lesions within the participant were compared. One area was received Metvix PDT at defined intervals and the other was received lesion specific treatment at the discretion of the investigator. The primary endpoint was the accumulated number of new lesions during the study and number of AK lesions that showed complete response 3 months after baseline. Secondary endpoints were number of BCC lesions that showed complete response, number of recurrent lesions, assessment of cosmetic outcome and safety.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• Number of Accumulated New Skin Lesions at Month 3

  A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of actinic keratoses (AK) lesions, basal cell carcinoma (BCC) lesions, squamous cell carcinoma (SCC) lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 3 were reported.

  At Month 3

• Number of Accumulated New Skin Lesions at Month 9

  A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 9 were reported.

  At Month 9

• Number of Accumulated New Skin Lesions at Month 15

  A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 15 were reported.

  At Month 15

• Number of Accumulated New Skin Lesions at Month 21

  A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 21 were reported.

  At Month 21

• Number of Accumulated New Skin Lesions at Month 27

  A new lesion was defined as a visible new lesion of any size after the Baseline. New skin lesions accumulated were sum of AK lesions, BCC lesions, SCC lesions and warts in treated area and contralateral control area (symmetrically). Number of accumulated new skin lesions at Month 27 were reported.

  At Month 27

• Number of AK Lesions That Showed Complete Response at Month 3

  Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.

  At Month 3

• Number of AK Lesions That Showed Complete Response at Month 9

  Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.

  At Month 9

• Number of AK Lesions That Showed Complete Response at Month 15

  Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.

  At Month 15

• Number of AK Lesions That Showed Complete Response at Month 21

  Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.

  At Month 21

• Number of AK Lesions That Showed Complete Response at Month 27

  Complete response was defined as the complete disappearance of the lesion. The AK lesions were graded as grade 1(mild); slightly palpable AK, better felt than seen, grade 2 (moderate); moderately thick AK, easily felt and seen, and grade 3 (severe); very thick and/or obvious AK. Mantel-Haenszel weighted difference was used to calculate number of AK lesions that showed complete response.

  At Month 27

Secondary Outcomes (4)

• Number of BCC Lesions That Showed Complete Response

  At Months 3, 9, 15, 21 and 27

• Number of Recurrent Lesions

  At Months 9, 15, 21 and 27

• Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants

  At Month 27

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Baseline up to Month 27

Study Arms (1)

Metvix®-PDT (Treatment Area +Contralateral Control Area)

EXPERIMENTAL

Two contralateral areas (symmetrically) were identified with an area of 5\*10-centimeter square, that is (i.e.), treatment and control area. Treatment area was treated with Metvix®-photodynamic therapy (PDT) 160 milligrams/gram (mg/g) cream, given as fractioned regimen consisting of two treatments one week apart on Weeks 0 and Week 1, additional single treatments were given at Months 3, 9, 15, 21 and 27. The contralateral control area was treated using lesion-specific treatment in accordance with the Investigator's preference (example, cryotherapy) at months 3, 9, 15, 21 and 27.

Procedure: Photodynamic therapy with Metvix 160 mg/g cream

Interventions

Photodynamic therapy with Metvix 160 mg/g cream PROCEDURE

Metvix®-PDT (Treatment Area +Contralateral Control Area)

Eligibility Criteria

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

You may qualify if:

• 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\^2 cm) in the face, the scalp, the extremities or on the trunk/neck.
• Transplant recipients who previously were treated more than once for their skin lesions.
• Transplant recipients who had received immunosuppressive therapy for more than 3 years.
• Males or females above 18 years of age.
• Written informed consent.

You may not qualify if:

• Participants with more than 10 skin lesions (AK, BCC, SCC in situ, warts) in one of the two areas.
• Participants with SCC (not SCC in situ) in one of the two areas.
• Participants not previously treated or treated only once for their skin lesions.
• Participants with rosacea in one of the two areas.
• Participants with morphea form/highly infiltrating BCC
• Known allergy to methyl-amino levulinate, 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 documented a negative pregnancy test and used the pill or IUD during the treatments and for at least one month thereafter).
• Conditions associated with a risk of poor protocol compliance

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (11)

Department of Dermatology, Århus Amysygehus

Aarhus, 8000, Denmark

Location

Department of Dermatology, Roskilde Amysygehus

Roskilde, 4000, Denmark

Location

Klinik für Dermatologie, Venerologie und Allergologie, Campus Charité Mitte

Berlin, 10117, Germany

Location

Hautklinik Linden

Hanover, 30449, Germany

Location

Department of Dermatology, Rikshospitalet

Oslo, 0027, Norway

Location

Department of Dermatology, St. Olavs Hospital

Trondheim, 7006, Norway

Location

Department of Dermatology, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Department of Dermatology, Karolinska University Hospital, Huddinge

Stockholm, 14186, Sweden

Location

Department of Dermatology, Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Dermatology Department, Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Portsmouth Dermatology Centre, St Mary's Hospital

Portsmouth, PO3 6AD, United Kingdom

Location

MeSH Terms

Conditions

Keratosis, Actinic; Warts; Carcinoma, Basal Cell; Bowen's Disease; Carcinoma, Squamous Cell

Interventions

Photochemotherapy; methyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Study Officials

• Ann-Marie Wennberg, MD, PhD

  Sahlgrenska University Hospital

  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: May 10, 2007
• First Posted: May 11, 2007
• Study Start: July 25, 2003
• Primary Completion: September 23, 2004
• Study Completion: July 14, 2006
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-03

Locations

DK (2); DE (2); SE (3); NO (2); GB (2)