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Last Updated: February 3, 2023

CLINICAL TRIALS PROFILE FOR AMELUZ

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All Clinical Trials for Ameluz

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Trial ID	Title	Status	Sponsor	Phase	Start Date	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	2013-08-01	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	2013-10-01	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	Completed	Accovion GmbH	Phase 3	2014-01-28	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).
NCT02144077 ↗	Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy	Completed	Biofrontera Bioscience GmbH	Phase 3	2014-01-28	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).
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Clinical Trial Conditions for Ameluz

Condition Name

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Condition Name for Ameluz
Intervention	Trials
Actinic Keratosis	5
Actinic Keratoses	2
Lentigo Maligna	1
Microvesicle Particle	1
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Condition MeSH

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Condition MeSH for Ameluz
Intervention	Trials
Keratosis, Actinic	8
Keratosis	8
Carcinoma	1
Mycosis Fungoides	1
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Clinical Trial Locations for Ameluz

Trials by Country

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

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

Clinical Trial Phase

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Clinical Trial Phase for Ameluz
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	4
Phase 2	1
[disabled in preview]	3
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Clinical Trial Status

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Clinical Trial Status for Ameluz
Clinical Trial Phase	Trials
Completed	9
Recruiting	2
Not yet recruiting	1
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Clinical Trial Sponsors for Ameluz

Sponsor Name

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

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Sponsor Type for Ameluz
Sponsor	Trials
Other	16
Industry	7
NIH	1
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