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Generated: February 22, 2019

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CLINICAL TRIALS PROFILE FOR AMELUZ

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Clinical Trials for Ameluz

Trial ID Title Status Sponsor Phase Summary
NCT01893203 Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL) Completed Joint Authority for Päijät-Häme Social and Health Care Phase 4 The aim of the study is to compare the efficacy of two photosensitizers, methyl-aminolaevulinate (MAL) and 5-aminolaevulinic nanoemulsion (BF-200 ALA) in the treatment of facial actinic keratosis. We use randomized, double-blinded prospective study design. The efficacy will be assessed clinically, histopathologically and immunohistochemically.
NCT01966120 Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT) Completed Biofrontera Bioscience GmbH Phase 3 The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp.
NCT02144077 Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy Active, not recruiting Accovion GmbH Phase 3 The aim of this study is to test the effectiveness and safety of the medicine Ameluz®, used with photodynamic therapy (PDT), to treat thin, non-aggressive rodent ulcer.
NCT02144077 Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy Active, not recruiting Biofrontera Bioscience GmbH Phase 3 The aim of this study is to test the effectiveness and safety of the medicine Ameluz®, used with photodynamic therapy (PDT), to treat thin, non-aggressive rodent ulcer.
NCT02464709 Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL) Recruiting Päijänne Tavastia Central Hospital Phase 4 This study compares two photosensitizing creams' BF-200 ALA's (aminolevulinic acid, Ameluz®) and MAL's (methyl 5-aminolevulinate, Metvix®) efficacy on actinic keratoses in natural daylight photodynamic therapy (NDL-PDT). The participants' facial skin or scalp will be randomized in two sides and one side is treated with BF-200 ALA and the other side with MAL. Result of the treatment is assessed with clinical examination 12 months after treatment. The investigators will also compare delayed skin reactions after treatment and cost-effectiveness of both photosensitizer creams.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ameluz

Condition Name

Condition Name for Ameluz
Intervention Trials
Actinic Keratosis 5
Refractory Mycosis Fungoides 1
Natural Daylight Photodynamic Therapy 1
Multiple Actinic Keratoses 1
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Condition MeSH

Condition MeSH for Ameluz
Intervention Trials
Keratosis, Actinic 6
Keratosis 6
Mycosis Fungoides 1
Mycoses 1
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Clinical Trial Locations for Ameluz

Trials by Country

Trials by Country for Ameluz
Location Trials
Finland 3
Germany 2
United States 1
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Trials by US State

Trials by US State for Ameluz
Location Trials
Arizona 1
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Clinical Trial Progress for Ameluz

Clinical Trial Phase

Clinical Trial Phase for Ameluz
Clinical Trial Phase Trials
Phase 4 3
Phase 3 4
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Ameluz
Clinical Trial Phase Trials
Completed 5
Recruiting 2
Not yet recruiting 1
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Clinical Trial Sponsors for Ameluz

Sponsor Name

Sponsor Name for Ameluz
Sponsor Trials
Biofrontera Bioscience GmbH 5
Joint Authority for Päijät-Häme Social and Health Care 3
University of Tampere 2
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Sponsor Type

Sponsor Type for Ameluz
Sponsor Trials
Other 11
Industry 7
NIH 1
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