CompletedPhase 3

Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)

Germany87 participantsStarted 2013-10

Plain-language summary

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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males or females between 18 and 85 years of age (inclusive) * Presence of 4 to 8 clinically confirmed actinic keratosis (AK) target lesions of mild to moderate intensity within 1-2 fields Exclusion Criteria: * History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA * Current treatment with immunosuppressive therapy * Presence of other malignant or benign tumors of the skin within the treatment area (eg malignant melanoma, basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)) within the last 4 weeks * Confirmed diagnosis of SCC for the representative lesion by screening biopsy

What they're measuring

Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT)

Timeframe: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT

Overall Patient Complete Response 12 Weeks After the Last PDT (PP)

Timeframe: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT

Trial details

NCT IDNCT01966120

SponsorBiofrontera Bioscience GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-09

Results submitted2016-06-10

View on ClinicalTrials.gov More Actinic Keratosis trials