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
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
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014