Phase 3
Completed N=571
Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy
Source: ClinicalTrials.gov NCT02799069 ↗Enrolled (actual)
571
Serious AEs
4.2%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT — 17.1; 78.2; 64.2 percentage of patients — p=0.0000
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT |
17.1; 78.2; 64.2 | 0.0000 sig |
| PRIMARY Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP |
20.0; 79.4; 65.3 | 0.0000 sig |
| PRIMARY Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only |
12.8; 84.8; 67.5 | 0.0000 sig |
| SECONDARY Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT) |
2.6; 34.7; 24.8 | — |
| SECONDARY Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT) |
3.9; 48.4; 37.0 | — |
| SECONDARY Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT) |
13.7; 48.4; 43.9 | — |
| SECONDARY Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT) |
13.7; 57.8; 43.2 | — |
| SECONDARY Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT) |
14.5; 54.0; 43.9 | — |
| SECONDARY Percentage of Participants With Partial Response at 3-4 Weeks After First Photodynamic Therapy (PDT) |
2.6; 50.0; 45.9 | — |
| SECONDARY Percentage of Participants With Partial Response at 12 Weeks After the First Photodynamic Therapy (PDT) |
13.2; 58.9; 53.3 | — |
| SECONDARY Percentage of Participants With Partial Response at 3-4 Weeks After the Second Photodynamic Therapy (PDT) |
20.5; 68.0; 62.6 | — |
| SECONDARY Percentage of Participants With Partial Response at 12 Weeks After the Second Photodynamic Therapy (PDT) |
23.3; 73.4; 65.2 | — |
| SECONDARY Percentage of Participants With Partial Response at 3-4 Weeks After Last Photodynamic Therapy (PDT) |
21.1; 70.6; 64.6 | — |
| SECONDARY Percentage of Participants With Partial Response at 12 Weeks After Last Photodynamic Therapy (PDT) |
26.3; 87.1; 78.0 | — |
| SECONDARY Complete Lesion Response Rate 3-4 Weeks After First Photodynamic Therapy (PDT) |
12.7; 63.9; 58.8 | — |
| SECONDARY Complete Lesion Response Rate 12 Weeks After First Photodynamic Therapy (PDT) |
24.7; 73.8; 66.5 | — |
| SECONDARY Complete Lesion Response Rate 3-4 Weeks After the Second Photodynamic Therapy (PDT) |
16.3; 60.4; 54.8 | — |
| SECONDARY Complete Lesion Response Rate 12 Weeks After Second PDT |
22.0; 69.3; 58.0 | — |
| SECONDARY Complete Lesion Response Rate 3-4 Weeks After Last Photodynamic Therapy (PDT) |
31.4; 79.0; 73.5 | — |
| SECONDARY Complete Lesion Response Rate 12 Weeks After Last Photodynamic Therapy (PDT) |
37.1; 90.4; 83.2 | — |
| SECONDARY Complete Lesion Response Rates 12 Weeks After Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only |
32.5; 93.6; 89.3 | — |
| SECONDARY Change From Baseline in Total Lesion Area 3-4 Weeks After the First Photodynamic Therapy (PDT) |
-26.9; -78.9; -75.7 | — |
| SECONDARY Change From Baseline in Total Lesion Area 12 Weeks After the First Photodynamic Therapy (PDT) |
-37.0; -85.4; -80.9 | — |
| SECONDARY Change From Baseline in Total Lesion Area 3-4 Weeks After the Second Photodynamic Therapy (PDT) |
-46.2; -91.4; -87.5 | — |
| SECONDARY Change From Baseline in Total Lesion Area 12 Weeks After Second Photodynamic Therapy (PDT) |
-50.1; -92.3; -88.9 | — |
| SECONDARY Change From Baseline in Total Lesion Area 3-4 Weeks After Last Photodynamic Therapy (PDT) |
-43.8; -89.4; -86.6 | — |
| SECONDARY Change From Baseline in Total Lesion Area 12 Weeks After Last Photodynamic Therapy (PDT) |
-48.5; -95.0; -92.0 | — |
| SECONDARY Overall Cosmetic Outcome of the Treated Skin 12 Weeks After Last Photodynamic Therapy (PDT) Compared to Baseline |
29.4; 36.0; 37.1; 14.7; 16.5; 19.2 | — |
| SECONDARY Local Skin Reactions During First Photodynamic Therapy (PDT-1) |
32.9; 72.6; 71.1; 1.3; 22.2; 23.6 | — |
| SECONDARY Local Skin Reactions During Second Photodynamic Therapy (PDT-2) for Retreated Subjects |
19.1; 61.8; 70.0; 0.0; 10.6; 11.3 | — |
| SECONDARY Local Discomfort During First Photodynamic Therapy (PDT-1) |
2.6; 9.7; 14.6; 28.9; 81.9; 85.8 | — |
| SECONDARY Local Discomfort During Second Photodynamic Therapy (PDT-2) for Retreated Subjects |
0.0; 7.3; 8.7; 14.7; 69.9; 74.7 | — |
| SECONDARY Local Discomfort - Pain During First Photodynamic Therapy (PDT-1) |
0.5; 4.4; 4.4 | — |
| SECONDARY Local Discomfort - Pain During Second Photodynamic Therapy (PDT-2) for Retreated Subjects |
0.3; 3.1; 3.3 | — |
| SECONDARY Adverse Reactions |
25; 219; 222; 31; 198; 199 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Written informed consent.
- Men and women between 18 and 85 years of age.
- 4-8 AK lesions of 0.5 to 1.5 cm diameter of mild to moderate intensity (Olsen grade 1 and 2) in the face and/or on the bald scalp. Lesions on the eyes, nostrils, ears and mouth were not considered for treatment during the planned study.
- Target AK lesions were to be discrete and quantifiable; adjacent AK lesions were to show a minimum distance of 1.0 cm from one another.
- Confirmation of AK by biopsy taken at screening.
- Free of significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment region that could have caused difficulty with examination or final evaluation.
- Willingness to stop the use of moisturizers and any other topical treatments within the treatment region.
- Good general health condition.
- Healthy subjects and subjects with clinically stable medical conditions including, but not limited to the following diseases (controlled hypertension, diabetes mellitus type II, hypercholesterolemia, osteoarthritis) were permitted to be included in the study if the medication taken for the treatment of the disease did not match an exclusion criterion or was not specified as prohibited concomitant medication.
- No extensive sunbathing or solarium use during the trial.
- Negative pregnancy test at screening.
Main exclusion criteria:
- Known hypersensitivity to BF-200 ALA, MAL (methyl-aminolevulinic acid) and/or any of the ingredients of the formulations
- Clinically significant medical conditions (tumor disease etc.) making implementation of the protocol or interpretation of the study results difficult
- Presence of photodermatoses
- Presence of other tumors in the treatment areas within the last 4 weeks
- Start of treatment with phototoxic or photoallergic drugs within 8 weeks prior to screening
- Current treatment with immunosuppression therapy
- Hypersensitivity to porphyrins
- Presence of porphyria
- Presence of inherited or acquired coagulation defect
- Any topical treatment within the treatment area within 12 weeks before PDT1 (first PDT Treatment)
- Topical treatment with ALA or MAL outside the treatment area during participation in the study
- None of the specified systemic treatments within the designated period before PDT1
Data sourced from ClinicalTrials.gov (NCT02799069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.