Phase 3
N=66
PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Call Carcinoma
Basal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00472043 ↗Enrolled (actual)
66
Serious AEs
4.6%
Results posted
Aug 2024
Primary outcome: Primary: Percentage of Participants With Histologically Confirmed Complete Response (CR) — 67; 18 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PDT with Metvix 160 mg/g cream (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Sep 2002
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Histologically Confirmed Complete Response (CR) |
67; 18 | <0.001 sig |
| SECONDARY Percentage of Lesions Per Participant: Histologically Confirmed Participant Weighted Response |
67.6; 19.4 | — |
| SECONDARY Histological Lesion Response |
23; 7; 8; 29; 3; 0 | — |
| SECONDARY Percentage of Participants With Clinically Confirmed Participant Complete Response (CR) |
82; 24 | — |
| SECONDARY Cosmetic Outcomes for Lesions Assessed by Investigator |
13; 2; 8; 3; 1; 1 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) and AEs Leading to Discontinuation |
1; 2; 1; 0 | — |
| SECONDARY Cosmetic Outcomes for Lesions Assessed by Participants |
14; 5; 8; 1; 0; 0 | — |
Summary
Photodynamic therapy (PDT) was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulated more photosensitiser than normal cells. The photosensitiser generated reactive oxygen species upon illumination.
For skin diseases, there had been an increasing interest in using precursors of the endogenous photosensitiser protoporphyrin IX (PpIX). The most commonly used precursors had been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug, Metvix®, contained the methyl ester of ALA, which penetrated the lesions well and shows high lesion selectivity .
In vitro studies of animal and human tissues had shown significant intracellular formation of photoactive porphyrins after addition of Metvix®. The increased levels of photoactive porphyrins induced cytotoxic effects in tumour cells after photoactivation.
The primary objective was to compare PDT with Metvix® cream to PDT with placebo cream in terms of participant complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle.
Secondary objectives were to compare the two treatments in terms of histological and clinical mean participant response weighted by the number of lesions within a participant, lesion response rates across participants, clinical complete participant response, cosmetic outcome and adverse events.
Eligibility Criteria
Inclusion Criteria
A participant with primary, nodular BCC lesion(s) suitable for entry is defined as a participant with
- Clinically diagnosed primary nodular BCC lesion(s).
- Histologically confirmed diagnosis of BCC.
- BCC lesions suitable for simple excision surgery.
- Males or females above 18 years of age.
- Written informed consent.
Exclusion Criteria
A participant that is ineligible for inclusion is a participant fulfilling any of the following criteria:
- Participants with porphyria.
- Participant with Gorlin's syndrome.
- Participant with Xeroderma pigmentosum.
- Participants concurrently receiving immunosuppressive medication.
- Participants with a history of arsenic exposure.
- Known allergy to Metvix®, a similar PDT 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 use adequate contraception (e.g. barrier methods, oral contraceptives or intrauterine device) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment.
- Conditions associated with a risk of poor protocol compliance.
Lesion Exclusion Criteria:
- A nodular BCC lesion in periorbital area, ears and nasolabial fold.
- A nodular BCC lesion with the longest diameter less than 6 mm or larger than 15 mm in face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on truncus.
- Pigmented nodular BCC lesion(s).
- Morpheaform nodular BCC lesion(s).
- Infiltrating nodular BCC lesion(s).
- Prior treatment of the BCC lesion(s).
Data sourced from ClinicalTrials.gov (NCT00472043). 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.