Phase 3 N=162 Randomized Prevention

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

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

Bottom Line

View on ClinicalTrials.gov: NCT00472459 ↗

Enrolled (actual)

162

Serious AEs

12.8%

Results posted

Apr 2025

Primary outcome: Primary: Number of Accumulated New Skin Lesions at Month 3 — 65; 103 new skin lesions — p=0.0120

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Photodynamic therapy with Metvix 160 mg/g cream (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Sep 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Accumulated New Skin Lesions at Month 3	65; 103	0.0120 sig
PRIMARY Number of Accumulated New Skin Lesions at Month 9	92; 85	0.1761
PRIMARY Number of Accumulated New Skin Lesions at Month 15	73; 87	0.1183
PRIMARY Number of Accumulated New Skin Lesions at Month 21	55; 47	0.2322
PRIMARY Number of Accumulated New Skin Lesions at Month 27	38; 52	0.1286
PRIMARY Number of AK Lesions That Showed Complete Response at Month 3	296; 240	—
PRIMARY Number of AK Lesions That Showed Complete Response at Month 9	311; 262	—
PRIMARY Number of AK Lesions That Showed Complete Response at Month 15	286; 236	—
PRIMARY Number of AK Lesions That Showed Complete Response at Month 21	275; 224	—
PRIMARY Number of AK Lesions That Showed Complete Response at Month 27	265; 206	—
SECONDARY Number of BCC Lesions That Showed Complete Response	1; 2; 0; 2; 0; 2	—
SECONDARY Number of Recurrent Lesions	24; 14; 31; 20; 12; 8	—
SECONDARY Number of Participants With Overall Cosmetic Outcome Assessed by Investigator and Participants	50; 50; 5; 5; 51; 52	—
SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	61; 39; 27; 4; 1; 26	—

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.

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 5x10^2 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.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00472459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.