A Multicenter, Phase III, Randomised Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Comparison With Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma

NCT00469417 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Galderma R&D
Phase	Phase 3
Status	COMPLETED
Enrolment	120
Start date	1999-10-18
Completion	2005-04

Conditions

• Superficial Basal Cell Carcinoma

Interventions

• Metvix® cream
• Hand held liquid nitrogen spray cryotherapy

Primary outcomes

• Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT or Cryotherapy Cycle — 3 months after last Metvix PDT or Cryotherapy cycle, up to 6 months
  Patient Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination.

Countries

Austria, Belgium, Finland, France, Italy, Sweden, United Kingdom