Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses (COMET2)

Galderma

Status and phase: Completed; Phase 3

Conditions: Actinic Keratoses

Treatments: Drug: c-PDT; Drug: NDL-PDT; Drug: placebo c-PDT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01821391

RD.03.SPR.29112

Details and patient eligibility

About

This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study.

The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the scalp on treated areas
• Subject with two symmetrical treated areas half scalps or two half faces excluding ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no more than a twofold difference in terms of total number of lesions between the two TAs

Exclusion criteria

• Subject with clinical diagnosis of at least one severe (Grade 3) AK on treated areas
• Subject with pigmented AK on the treated areas
• Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons
• Subject with porphyria,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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131 participants in 2 patient groups

NDL-PDT/c-PDT

Experimental group

Description:

Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy

Treatment:

Drug: c-PDT

Drug: NDL-PDT

NDL-PDT/placebo c-PDT

Experimental group

Description:

Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy

Treatment:

Drug: placebo c-PDT

Drug: NDL-PDT