CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 122 enrolled
Drug / intervention
Vehicle +1 moredrug
Likely dose
BF-200 ALA topical application followed by illumination with broad or narrow spectrum light sources after 3 hours of drug incubationAI-extracted
Key inclusion· 6
  • ✓Men and women aged 18 to 85 years
  • ✓At least 4 but not more than 8 clinically confirmed actinic keratosis target lesions of mild to moderate intensity (AK grade I and II) within face or bald scalp
  • ✓Each AK lesion diameter 0.5–1.5 cm; lesions separated by >1.0 cm
  • ✓General good and stable health condition confirmed by physical examination and medical history
Key exclusion· 14
  • ✕Known hypersensitivity to 5-aminolevulinic acid (ALA)
  • ✕Under immunosuppressive therapy
  • ✕History of porphyria, hypersensitivity to porphyrins, or photodermatoses
  • ✕Inherited or acquired coagulation defects

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02799082
NCT02799082Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Phase III Multi-Center Study Evaluating the Safety and Efficacy of BF-200 ALA Versus Placebo in the Treatment of Actinic Keratosis (AK) When Using PDT

Biofrontera Bioscience GmbH·interventional·Posted Jun 14, 2016·Updated Apr 6, 2017

In Brief

A Phase 3 clinical trial evaluating Vehicle and BF-200 ALA for Actinic Keratosis. Completed, enrolled 122 participants.

Detailed Summary

The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with photodynamic therapy (PDT) in patients suffering from actinic keratosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 14, 2016
Enrollment StartDec 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.0 years ago

Interventions

Vehicledrug

topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).

BF-200 ALAdrug

topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).