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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.

Clinical Trial Conditions for Ameluz

Condition Name

Condition Name for Ameluz
Intervention	Trials
Actinic Keratosis	5
Basal Cell Carcinoma (BCC)	1
Refractory Mycosis Fungoides	1
Natural Daylight Photodynamic Therapy	1

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Condition MeSH

Condition MeSH for Ameluz
Intervention	Trials
Keratosis, Actinic	6
Keratosis	6
Lentigo	1
Hutchinson's Melanotic Freckle	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
Active, not 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
Accovion GmbH	2

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Sponsor Type

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

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