CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
BF-200 ALA and red light LED lampcombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT04319159
NCT04319159Phase 1Completed
CompareCT.gov

An Open-label Phase I Study to Evaluate the Pharmacokinetics of 5-aminolevulinic Acid and Protoporphyrin IX in Human Plasma Under Maximal Use Conditions After Topical Application of 3 Tubes of BF-200 ALA 10% Gel for Photodynamic Therapy (PDT) in Subjects Suffering From Actinic Keratosis

Biofrontera Bioscience GmbH·interventional·Posted Mar 24, 2020·Updated Nov 11, 2021

In Brief

A Phase 1 clinical trial evaluating BF-200 ALA and red light LED lamp for Actinic Keratoses. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The aim of this study is to assess the pharmacokinetics (PK) of the parent drug 5-aminolevulinic acid (ALA) and its active metabolite protoporphyrin IX (PpIX) during photodynamic therapy with 3 tubes of BF-200 ALA 10% gel (Ameluz®) in combination with the BF-RhodoLED® lamp in the systemic circulation of diseased individuals presenting with actinic keratosis (AK) on the face/scalp or in the periphery (neck/trunk/extremities) along with subjects' safety/tolerability during and after treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratoses
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedMar 24, 2020
Enrollment StartMar 5, 2020
Primary CompletionSep 9, 2020
Study CompletionOct 7, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.3 years ago

Interventions

BF-200 ALA and red light LED lampcombination

Combination Product: Photodynamic therapy (PDT) using BF-RhodoLED® (ALA-PDT, Ameluz®-PDT).