Phase 3
N=120
Metvix Photodynamic Therapy (PDT) Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma
Superficial Basal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00469417 ↗Enrolled (actual)
120
Serious AEs
7.6%
Results posted
Aug 2024
Primary outcome: Primary: Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle — 92; 90 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metvix® cream (Drug); Hand held liquid nitrogen spray cryotherapy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Sep 2001
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle |
92; 90 | — |
| SECONDARY Number of Lesion With Complete Response 3 Months After Last Metvix PDT or Cryotherapy Cycle |
109; 94 | — |
| SECONDARY Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT or Cryotherapy Cycle |
17; 2; 30; 23; 6; 25 | — |
| SECONDARY Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT or Cryotherapy Cycle |
22; 9; 24; 24; 0; 11 | — |
| SECONDARY Recurrence Rate in Complete Clearance Group |
10; 12; 18; 18; 23; 18 | — |
| SECONDARY Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT or Cryotherapy Cycle |
19; 3; 12; 15; 3; 20 | — |
Summary
The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) methyl aminolevulinate (MAL) cream to cryotherapy, in treatment of participants with primary superficial basal cell carcinoma (BCC).
Secondary objectives was to compare cosmetic outcome and tolerability (adverse events) in these participants, 3 months after treatment. In addition the recurrence rates in the two treatment groups will be compared up to five years after treatment.
Eligibility Criteria
Inclusion Criteria
A participant with superficial BCC lesion(s) suitable for entry was defined as a participant with:
- histologically confirmed diagnosis of primary superficial BCC lesion(s)
- BCC lesions suitable for cryotherapy
- males or females above 18 years of age
- written informed consent. In accordance with Amendment 2 (local amendment), only participant above 19 years of age were to be included in Austria.
Exclusion Criteria
A participant or lesion fulfilling any of the following criteria was ineligible for inclusion:
- prior treatment of the BCC lesion(s)
- participant with more than 10 eligible BCC lesions
- a superficial BCC lesion with the largest diameter exceeding 15 mm on face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on the trunk
- a superficial BCC lesion with the largest diameter smaller than 6 mm
- participant with porphyria
- participant with Gorlin's syndrome
- pigmented superficial BCC lesion(s)
- morpheaform lesion(s)
- infiltrating lesion(s)
- 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 had to document a negative pregnancy test and use the pill or intrauterine device during the treatments and for at least one month thereafter
- conditions associated with a risk of poor protocol compliance.
In Amendment 1 the following exclusion criteria were added:
- xeroderma pigmentosum lesion
- concurrent use of immunosuppressive medication.
Data sourced from ClinicalTrials.gov (NCT00469417). 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.