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Trial record 3 of 2455 for:    ALA

Evaluation of Efficacy and Safety of BF-200 ALA Used With Photodynamic Therapy in Patients With Actinic Keratosis.

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ClinicalTrials.gov Identifier: NCT02799082
Recruitment Status : Completed
First Posted : June 14, 2016
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Biofrontera Bioscience GmbH

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Actinic Keratosis
Interventions: Drug: Vehicle
Drug: BF-200 ALA

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study period: December 13, 2007 to October 01, 2008. Patients were recruited at 8 study centers in Germany (hospitals and private practices).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
128 patients were screened, of whom 122 patients were randomized (41 patients to the vehicle/placebo group, 81 patients to the BF-200 ALA group); 6 patients were screening failures (3 patients refused to participate, 3 patients meet exclusion criteria).

Reporting Groups
  Description
Vehicle

Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.

Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).

BF-200 ALA

Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.

BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).


Participant Flow:   Overall Study
    Vehicle   BF-200 ALA
STARTED   41   81 
COMPLETED   37   77 
NOT COMPLETED   4   4 
Refused second PDT or withdraw consent                4                3 
Protocol Violation                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline description is given for the FAS (Full Analysis Set). One patient each in the vehicle/placebo groupd and in the BF-200 ALA group dropped out without a post-treatment assessment of the target lesions and thus were not considered for the FAS.

Reporting Groups
  Description
Vehicle

Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.

Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).

BF-200 ALA

Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.

BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).

Total Total of all reporting groups

Baseline Measures
   Vehicle   BF-200 ALA   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   80   120 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5  12.5%      10  12.5%      15  12.5% 
>=65 years      35  87.5%      70  87.5%      105  87.5% 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.8  (6.7)   70.4  (5.2)   70.5  (5.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  22.5%      8  10.0%      17  14.2% 
Male      31  77.5%      72  90.0%      103  85.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      40 100.0%      80 100.0%      120 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
Germany   40   80   120 
Maximal severity of AK at baseline 
[Units: Participants]
     
mild   11   19   30 
moderate   29   61   90 


  Outcome Measures

1.  Primary:   Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)   [ Time Frame: 12 weeks after the last photodynamic therapy (PDT), up to 24 weeks ]

2.  Primary:   Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)   [ Time Frame: 12 weeks after the last PDT, up to 24 weeks ]

3.  Primary:   Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)   [ Time Frame: 12 weeks after the last PDT, up to 24 weeks ]

4.  Primary:   Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)   [ Time Frame: 12 weeks after the last PDT, up to 24 weeks ]

5.  Secondary:   Percentage of AK Lesions Showing Complete Remission 12 Weeks After the Last PDT   [ Time Frame: 12 weeks after the last PDT, up to 24 weeks ]

6.  Secondary:   Percentage of AK Lesions Showing Complete Remission Treated With Narrow Spectrum Lamp 12 Weeks After the Last PDT   [ Time Frame: 12 weeks after the last PDT, up to 24 weeks ]

7.  Secondary:   Change in Total Lesion Size 12 Weeks After the Last PDT   [ Time Frame: 12 weeks after the last PDT, up to 24 weeks ]

8.  Secondary:   Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Face)   [ Time Frame: 12 weeks after the last PDT, up to 24 weeks ]

9.  Secondary:   Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Scalp)   [ Time Frame: 12 weeks after the last PDT, up to 24 weeks ]

10.  Secondary:   Subjects With Complete Clearance 12 Weeks After the First PDT   [ Time Frame: 12 weeks after the first PDT ]

11.  Secondary:   Subjects With Partial Clearance 12 Weeks After the Last PDT   [ Time Frame: 12 weeks after the last PDT, up to 24 weeks ]

12.  Secondary:   Overall Cosmetic Outcome 12 Weeks After the Last PDT   [ Time Frame: 12 weeks after the last PDT, up to 24 weeks ]

13.  Secondary:   Local Skin Reactions   [ Time Frame: during and after PDT [3h - 4 h] ]

14.  Secondary:   Discomfort During and After PDT   [ Time Frame: during and after PDT [3h - 4 h] ]

15.  Secondary:   Related Adverse Events /AEs)   [ Time Frame: up to 24 weeks after the 1st PDT ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Beate Schmitz
Organization: Biofrontera Bioscience GmbH
phone: +49 214 876 32 ext 41
e-mail: b.schmitz@biofrontera.com


Publications of Results:

Responsible Party: Biofrontera Bioscience GmbH
ClinicalTrials.gov Identifier: NCT02799082     History of Changes
Other Study ID Numbers: ALA-AK-CT003
First Submitted: May 27, 2016
First Posted: June 14, 2016
Results First Submitted: August 1, 2016
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017