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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
Enrollment 14

Recruitment Details  
Pre-assignment Details  
Arm/Group Title BF200 ALA vs MAL
Hide Arm/Group Description 5-aminulevulinic acid nanoemulsion (BF-200 ALA, Ameluz, Biofrontera) and methylaminolevulinic acid (MAL, Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
Period Title: Overall Study
Started 14
Completed 13
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title BF-200 ALA vs MAL
Hide Arm/Group Description BF-200 ALA cream and MAL (Metvix, Galderma) used in a randomized split-face design
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
14 patients were recruited. One withdrew because of conditions not related to the study. This patient was not included in the analysis.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
79.8
(66 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
Number of AKs  
Measure Type: Number
Unit of measure:  Number of actinic keratoses (AKs)
Number Analyzed 13 participants
177
1.Primary Outcome
Title Histological Lesion Clearance
Hide Description Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal)
Time Frame 0 (baseline) and 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Punch biopsies bilaterally on treatment fields
Arm/Group Title BF200 ALA vs MAL
Hide Arm/Group Description:
BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: percentage of complete clearance
BF-200 ALA 61.5
MAL 38.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BF200 ALA vs MAL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.375
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
2.Secondary Outcome
Title Pain
Hide Description

Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m.

(treatment day). Of these values, the mean maximal pain is assessed.

Time Frame 12 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients
Arm/Group Title BF200 ALA vs MAL
Hide Arm/Group Description:
BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
Overall Number of Participants Analyzed 13
Mean (Full Range)
Unit of Measure: units on a scale
BF-200 ALA treatment sides
1.7
(0.4 to 8.6)
MAL treatment sides
1.9
(0.2 to 8.6)
3.Secondary Outcome
Title Clinical Lesion Clearance
Hide Description Clinical lesion clearance is observed by a blinded observer
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BF200 ALA vs MAL
Hide Arm/Group Description:
BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
Overall Number of Participants Analyzed 13
Overall Number of Units Analyzed
Type of Units Analyzed: AKs total
177
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of complete clearance
BF-200 ALA treated lesions
84.5
(75.2 to 90.9)
MAL treated lesions
74.2
(64.4 to 82.1)
4.Other Pre-specified Outcome
Title Adverse Reactions
Hide Description Adverse reactions are evaluated by blinded observer at one week after treatment. A dermatologist will assess which side of the face or scalp presents a stronger reaction.
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One week after the first photodynamic therapy (PDT), seven patients had more severe reactions (erythema, crusting) at the site treated with BF-200 ALA, five patients had more severe reactions at the MAL site and one patient showed no difference between sites.
Arm/Group Title BF200 ALA vs MAL
Hide Arm/Group Description:
BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
BF-200 ALA treated areas 7
MAL treated areas 5
No difference between the sides 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BF200 ALA vs MAL
Hide Arm/Group Description BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized slipt face design on symmetrical treatment areas.
All-Cause Mortality
BF200 ALA vs MAL
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
BF200 ALA vs MAL
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BF200 ALA vs MAL
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Skin and subcutaneous tissue disorders   
Adverse reactions: erythema, crusting, scaling  [1]  13/13 (100.00%)  13
Pain  [2]  13/13 (100.00%)  13
Indicates events were collected by systematic assessment
[1]
Erythema, crusting and scaling were assessed all together as one score of mild, moderate or severe
[2]
Pain in VAS scale 1-10
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
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