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Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL) (2013-002108-15)

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ClinicalTrials.gov Identifier: NCT01893203
Recruitment Status : Completed
First Posted : July 8, 2013
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Joint Authority for Päijät-Häme Social and Health Care

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Multiple Actinic Keratoses
Interventions: Drug: BF-200 ALA cream
Drug: MAL cream

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BF200 ALA vs MAL 5-aminulevulinic acid nanoemulsion (BF-200 ALA, Ameluz, Biofrontera) and methylaminolevulinic acid (MAL, Metvix, Galderma) in randomized split face design on symmetrical treatment areas.

Participant Flow:   Overall Study
    BF200 ALA vs MAL
STARTED   14 
COMPLETED   13 
NOT COMPLETED   1 
Withdrawal by Subject                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.
14 patients were recruited. One withdrew because of conditions not related to the study. This patient was not included in the analysis.

Reporting Groups
  Description
BF-200 ALA vs MAL BF-200 ALA cream and MAL (Metvix, Galderma) used in a randomized split-face design

Baseline Measures
   BF-200 ALA vs MAL 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Years]
Mean (Full Range)
 79.8 
 (66 to 88) 
Gender 
[Units: Participants]
 
Female   6 
Male   7 
Number of AKs 
[Units: Number of actinic keratoses (AKs)]
 177 


  Outcome Measures

1.  Primary:   Histological Lesion Clearance   [ Time Frame: 0 (baseline) and 3 months ]

2.  Secondary:   Pain   [ Time Frame: 12 hours ]

3.  Secondary:   Clinical Lesion Clearance   [ Time Frame: 3 months ]

4.  Other Pre-specified:   Adverse Reactions   [ Time Frame: 1 week ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Noora Neittaanmäki-Perttu
Organization: Helsinki university hospital
phone: +358407190362
e-mail: noora.neittaanmaki@fimnet.fi



Responsible Party: Joint Authority for Päijät-Häme Social and Health Care
ClinicalTrials.gov Identifier: NCT01893203     History of Changes
Other Study ID Numbers: R13073 / Q257
2013-002108-15 ( EudraCT Number )
First Submitted: July 2, 2013
First Posted: July 8, 2013
Results First Submitted: December 23, 2015
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016