Trial · NCT02799069
Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy
NCT02799069, Phase 3, Completed, Biofrontera Bioscience GmbH; results first posted 2017-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy. Trials, record NCT02799069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02799069
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy
- NCT number
- NCT02799069
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 571 participants, actual
- Lead sponsor
- Biofrontera Bioscience GmbH
- Conditions
- Actinic Keratosis
- Interventions
- BF-200 ALA, MAL Cream, Vehicle
- First posted
- 2016-06-14
- Last updated
- 2017-04-28
- Results first posted
- 2017-03-23
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT | 12 weeks after the last PDT, up to 24 weeks after the first treatment | An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT) |
| Primary | Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP | 12 weeks after the last PDT, up to 24 weeks after the first treatment | An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT) |
| Primary | Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only | 12 weeks after the last PDT, up to 24 weeks after the first treatment | Subgroup analysis of patients treated with a narrow spectrum device for PDT Illumination (\~630 nm). An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT) |
| Secondary | Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT) | 3-4 weeks after the first PDT | A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the first PDT. |
| Secondary | Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT) | 12 weeks after the first PDT | A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the first PDT. |
| Secondary | Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT) | 3-4 weeks after the second PDT, 15-16 weeks after first treatment | A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT. |
| Secondary | Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT) | 12 weeks after the second PDT, 24 weeks after first treatment | A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT. |
| Secondary | Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT) | 3-4 weeks after the last PDT, up to 16 weeks after the first treatment | A complete responder at week 3-4 after treatment was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission). This outcome measure considered patients who were completely cleared at 3-4 weeks after the last PDT which included complete responders 3-4 weeks after the first and complete responders 3-4 weeks after the second PDT ( a second PDT was applied in case of remaining lesions 12 weeks after the first PDT). |
| Secondary | Percentage of Participants With Partial Response at 3-4 Weeks After First Photodynamic Therapy (PDT) | 3-4 weeks after the first PDT | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the first PDT. |
| Secondary | Percentage of Participants With Partial Response at 12 Weeks After the First Photodynamic Therapy (PDT) | 12 weeks after the first PDT | A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the first PDT. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT | 12 weeks after the last PDT, up to 24 weeks after the first treatment | Intent-to-treat (ITT) | percentage of patients | NUMBER |
| PRIMARY | Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP | 12 weeks after the last PDT, up to 24 weeks after the first treatment | per protocol set (PP) | percentage of patients | NUMBER |
| PRIMARY | Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only | 12 weeks after the last PDT, up to 24 weeks after the first treatment | ITT | percentage of patients | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT) | 3-4 weeks after the first PDT | ITT | percentage of patients | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT) | 12 weeks after the first PDT | ITT | percentage of patients | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT) | 3-4 weeks after the second PDT, 15-16 weeks after first treatment | ITT | percentage of patients | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT) | 12 weeks after the second PDT, 24 weeks after first treatment | ITT | percentage of patients | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT) | 3-4 weeks after the last PDT, up to 16 weeks after the first treatment | ITT | percentage of patients | NUMBER |
| SECONDARY | Percentage of Participants With Partial Response at 3-4 Weeks After First Photodynamic Therapy (PDT) | 3-4 weeks after the first PDT | ITT | percentage of patients | NUMBER |
| SECONDARY | Percentage of Participants With Partial Response at 12 Weeks After the First Photodynamic Therapy (PDT) | 12 weeks after the first PDT | ITT | percentage of patients | NUMBER |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group204
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT | Vehicle | 17.1 | 95% Confidence Interval 9.4 to 27.5 | percentage of patients | |
| Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT | BF-200 ALA | 78.2 | 95% Confidence Interval 72.6 to 83.2 | percentage of patients | |
| Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT | MAL Cream | 64.2 | 95% Confidence Interval 57.9 to 70.2 | percentage of patients | |
| Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP | Vehicle | 20.0 | 95% Confidence Interval 11.1 to 31.8 | percentage of patients | |
| Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP | BF-200 ALA | 79.4 | 95% Confidence Interval 73.7 to 84.4 | percentage of patients | |
| Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP | MAL Cream | 65.3 | 95% Confidence Interval 58.8 to 71.3 | percentage of patients | |
| Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only | Vehicle | 12.8 | 95% Confidence Interval 4.3 to 27.4 | percentage of patients | |
| Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only | BF-200 ALA | 84.8 | 95% Confidence Interval 77.3 to 90.6 | percentage of patients | |
| Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only | MAL Cream | 67.5 | 95% Confidence Interval 58.5 to 75.5 | percentage of patients | |
| Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT) | Vehicle | 2.6 | 95% Confidence Interval 0.3 to 9.2 | percentage of patients |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vehicle | 76 | |
| Overall Study | STARTED | BF-200 ALA | 248 | |
| Overall Study | STARTED | MAL Cream | 247 | |
| Overall Study | ITT/Safety | Vehicle | 76 | |
| Overall Study | ITT/Safety | BF-200 ALA | 248 | |
| Overall Study | ITT/Safety | MAL Cream | 246 | |
| Overall Study | COMPLETED | Vehicle | 68 | |
| Overall Study | COMPLETED | BF-200 ALA | 241 | |
| Overall Study | COMPLETED | MAL Cream | 240 | |
| Overall Study | NOT COMPLETED | Vehicle | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events111
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Application site irritation | General disorders | Vehicle | 25 | 76 | |
| other | Application site irritation | General disorders | BF-200 ALA | 219 | 248 | |
| other | Application site irritation | General disorders | MAL Cream | 222 | 246 | |
| other | Application site erythema | General disorders | Vehicle | 31 | 76 | |
| other | Application site erythema | General disorders | BF-200 ALA | 198 | 248 | |
| other | Application site erythema | General disorders | MAL Cream | 199 | 246 | |
| other | Application site edema | General disorders | Vehicle | 1 | 76 | |
| other | Application site edema | General disorders | BF-200 ALA | 62 | 248 | |
| other | Application site edema | General disorders | MAL Cream | 61 | 246 | |
| other | Application site pain | General disorders | Vehicle | 19 | 76 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle | ||
| Total, all-cause mortality | BF-200 ALA | ||
| Total, all-cause mortality | MAL Cream | ||
| Total, other adverse events | Vehicle | 55 | 76 |
| Total, other adverse events | BF-200 ALA | 239 | 248 |
| Total, other adverse events | MAL Cream | 241 | 246 |
| Total, serious adverse events | Vehicle | 3 | 76 |
| Total, serious adverse events | BF-200 ALA | 11 | 248 |
| Total, serious adverse events | MAL Cream | 10 | 246 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02799069
GET https://conductscience.org/api/trials/v1/NCT02799069/registered?page=2