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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biofrontera Bioscience GmbH
ClinicalTrials.gov Identifier:
NCT01966120
First received: October 17, 2013
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Actinic Keratosis
Procedure: Photodynamic therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Phase III, Multi-center Study 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

Resource links provided by NLM:


Further study details as provided by Biofrontera Bioscience GmbH:

Primary Outcome Measures:
  • Patient complete response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Complete responder rate at week 12 after last PDT


Secondary Outcome Measures:
  • Safety and secondary efficacy parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Subject assessment of pain during PDT, lesion complete response, histopathological confirmed response rate


Enrollment: 87
Study Start Date: September 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BF-200 ALA
Photodynamic therapy with BF-200 ALA
Procedure: Photodynamic therapy
Other Names:
  • PDT
  • BF-RhodoLED
Placebo Comparator: Placebo to BF-200 ALA
Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
Procedure: Photodynamic therapy
Other Names:
  • PDT
  • BF-RhodoLED

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females between 18 and 85 years of age (inclusive)
  • Presence of 4 to 8 clinically confirmed 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966120

Locations
Germany
Dermatologisches Zentrum Bonn Friedensplatz
Bonn, Germany
Sponsors and Collaborators
Biofrontera Bioscience GmbH
Investigators
Principal Investigator: Uwe Reinhold, Prof. Dr. Dermatologisches Zentrum Bonn
  More Information

No publications provided

Responsible Party: Biofrontera Bioscience GmbH
ClinicalTrials.gov Identifier: NCT01966120     History of Changes
Other Study ID Numbers: ALA-AK-CT007, 2013-002510-12
Study First Received: October 17, 2013
Last Updated: March 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biofrontera Bioscience GmbH:
Photodynamic Therapy
Field-directed Treatment

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Neoplasms
Precancerous Conditions
Skin Diseases

ClinicalTrials.gov processed this record on November 23, 2014