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Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy

NCT02144077 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2022-11-03

Study results available
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Summary

The aim of this study is to test the effectiveness and safety of the medicine Ameluz® (5-aminolevulinic acid) in comparison to methyl-aminolevulinate (MAL), used with photodynamic therapy (PDT), to treat thin, non-aggressive BCC (basal cell carcinoma).

Conditions

  • Basal Cell Carcinoma (BCC)

Interventions

DRUG

BF-200 ALA

Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)

DRUG

methyl-aminolevulinate

Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)

Sponsors & Collaborators

  • Accovion GmbH

    collaborator INDUSTRY

  • Biofrontera Bioscience GmbH

    lead INDUSTRY

Principal Investigators

  • Rolf M. Szeimies, Prof. Dr. · Klinik fuer Dermatologie und Allergologie (Klinikum Vest - Knappschaftskrankenhaus), Recklinghausen, Germany

  • Colin Morton, Dr. · Dermatology Department, Stirling Community Hospital, NHS Forth Valley, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-28
Primary Completion
2015-11-17
Completion
2020-09-09

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02144077 on ClinicalTrials.gov