Trial intelligence / Profile preview

Topical ALA Penetration in Skin Cancer

NCT00002963Phase 2

Key facts

Status
Completed
Start
Nov 1993
Primary completion
Jun 2007
Countries
1
Modality
Small Molecules
Conditions
basal cell carcinoma (BCC)squamous cell carcinoma (SCC)
01

Overview

Phase 2, randomised, open-label trial of 5-aminolevulinic acid in basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) (2 arms), sponsored by Roswell Park Comprehensive Cancer Center. Primary endpoint: Depth of penetration of aminolevulinic acid. Started Nov 1993; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • 4-5 Hour Application

    Topical ALA applied for 4-5 hours

  • 20-24 Hour Application

    Topical ALA applied for 20-24 hours

03

Endpoints

Primary

  • Depth of penetration of aminolevulinic acid

Secondary

  • Depth of fluorescence

  • Comparison of tissue fluorescence with surface fluorescence

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