Trial · NCT01966120
Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)
NCT01966120, Phase 3, Completed, Biofrontera Bioscience GmbH; results first posted 2016-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT). Trials, record NCT01966120. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01966120
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)
- NCT number
- NCT01966120
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 87 participants, actual
- Lead sponsor
- Biofrontera Bioscience GmbH
- Conditions
- Actinic Keratosis
- Interventions
- BF-200 ALA gel, Placebo to BF-200 ALA gel, Photodynamic therapy with BF-RhodoLED
- First posted
- 2013-10-21
- Last updated
- 2023-07-28
- Other registries' IDs
- eudract:2013-002510-12
- Results first posted
- 2016-12-19
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation. Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed. The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated actinic keratosis (AK) lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed. |
| Primary | Overall Patient Complete Response 12 Weeks After the Last PDT (PP) | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation. Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed. The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated AK lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed. |
| Secondary | Patient Histopathological Confirmed Response Rate | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | For the secondary confirmatory analysis, several superiority hypotheses were tested within a pre-defined hierarchic multiple testing procedure as described in the Statistical Analysis Protocoll (SAP). The key secondary efficacy variables were tested strictly in a pre-defined order to ensure the family-wise error rate (FWER) and the testing procedure had to be stopped once the first non-significant test was obtained. The results of the confirmatory analysis are presented in the order pre-defined by the confirmatory testing procedure. Assessments of the patient histopathological confirmed response (HCR) rates were based on the results from the biopsy taken 12 weeks after the last PDT from a representative AK lesion selected at screening. If the biopsy result for a patient revealed a residual AK, the patient was considered "not cleared" for the analysis irrespectively of the investigator's clinical assessment. |
| Secondary | Patient Complete Response 12 Weeks After PDT 1 | 12 weeks after PDT 1 | The second key secondary efficacy variable in the hierarchic test procedure was the patient complete response (complete clearance of all treated AK lesions) assessed at 12 weeks after PDT 1. |
| Secondary | Lesion Complete Response 12 Weeks After Last PDT | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | The third key secondary efficacy variable in the hierarchic test procedure was the lesion complete response (completely cleared individual AK lesions) assessed at 12 weeks after last PDT. |
| Secondary | Patient Partial Response 12 Weeks After Last PDT | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | The fourth key secondary efficacy variable in the hierarchic test procedure was the patient partial response (defined as complete clearance of at least 75% of treated AK lesions) assessed at 12 weeks after last PDT. |
| Secondary | Change of Total Lesion Area 12 Weeks After Last PDT | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | The fifth key secondary efficacy variable in the hierarchic test procedure was the change from baseline in the total lesion area per patient assessed at 12 weeks after last PDT. |
| Secondary | Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 0 to 3 | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy. Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated). The outcome was calculated using a 5-point scale ranging from "very good" (0) to "impaired" (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened). |
| Secondary | Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 1 to 3 | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy. Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated). The outcome was calculated using a 5-point scale ranging from "very good" (0) to "impaired" (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened). |
| Other | Patient Recurrence Rate in Follow-up (Cumulative) | 12 months after last treatment (PDT-1 or PDT-2, if re-treated) | Cumulative numbers of patients with complete response who showed recurrences 12 months after last treatment (PDT-1 or PDT-2, if re-treated). A patient with complete response was regarded as recurrent if at least one baseline AK lesion recurred during the follow-up (FU). Complete response was achieved if all treated lesions of the patient were cleared 12 weeks after the last treatment (PDT-1 or PDT-2, if re-treated). Lesions that showed recurrence at 6-months (FU1) were also defined as recurrent at 12-months follow-up (FU2). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| PRIMARY | Overall Patient Complete Response 12 Weeks After the Last PDT (PP) | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | Per Protocol Set (PP) | percentage of participants | NUMBER |
| SECONDARY | Patient Histopathological Confirmed Response Rate | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | Full Analysis Set (FAS) 6 patients (1 BF-200 ALA and 5 Placebo patients) had a missing evaluation of the second biopsy 12 weeks after PDT. | percentage of participants | NUMBER |
| SECONDARY | Patient Complete Response 12 Weeks After PDT 1 | 12 weeks after PDT 1 | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| SECONDARY | Lesion Complete Response 12 Weeks After Last PDT | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | Full Analysis Set (FAS) | percentage of lesions | NUMBER |
| SECONDARY | Patient Partial Response 12 Weeks After Last PDT | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| SECONDARY | Change of Total Lesion Area 12 Weeks After Last PDT | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | Full Analysis Set (FAS) | percentage of lesion area change | MEAN |
| SECONDARY | Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 0 to 3 | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| SECONDARY | Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 1 to 3 | 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Patient Recurrence Rate in Follow-up (Cumulative) | 12 months after last treatment (PDT-1 or PDT-2, if re-treated) | Full analysis set in follow-up phase (FAS-FUP). Recurrence rate was only analyzed in patients with complete clearance/response 12 weeks after the last treatment (PDT-1 or PDT-2, if re-treated). Complete response was achieved if all treated lesions of the patient were cleared 12 weeks after the last treatment (PDT-1 or PDT-2, if re-treated). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group162
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) | BF-200 ALA | 90.9 | 95% Confidence Interval 80 to 97 | percentage of participants | |
| Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) | Placebo to BF-200 ALA | 21.9 | 95% Confidence Interval 9.3 to 40 | percentage of participants | |
| Overall Patient Complete Response 12 Weeks After the Last PDT (PP) | BF-200 ALA | 90.0 | 95% Confidence Interval 78.2 to 96.7 | percentage of participants | |
| Overall Patient Complete Response 12 Weeks After the Last PDT (PP) | Placebo to BF-200 ALA | 25.9 | 95% Confidence Interval 11.1 to 46.3 | percentage of participants | |
| Patient Histopathological Confirmed Response Rate | BF-200 ALA | 77.8 | 95% Confidence Interval 64.4 to 88 | percentage of participants | |
| Patient Histopathological Confirmed Response Rate | Placebo to BF-200 ALA | 22.2 | 95% Confidence Interval 8.6 to 42.3 | percentage of participants | |
| Patient Complete Response 12 Weeks After PDT 1 | BF-200 ALA | 61.8 | 95% Confidence Interval 47.7 to 74.6 | percentage of participants | |
| Patient Complete Response 12 Weeks After PDT 1 | Placebo to BF-200 ALA | 9.4 | 95% Confidence Interval 2 to 25 | percentage of participants | |
| Lesion Complete Response 12 Weeks After Last PDT | BF-200 ALA | 94.3 | 95% Confidence Interval 91 to 96.6 | percentage of lesions | |
| Lesion Complete Response 12 Weeks After Last PDT | Placebo to BF-200 ALA | 32.9 | 95% Confidence Interval 26 to 40.5 | percentage of lesions |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BF-200 ALA | 55 | |
| Overall Study | STARTED | Placebo to BF-200 ALA | 32 | |
| Overall Study | COMPLETED | BF-200 ALA | 54 | |
| Overall Study | COMPLETED | Placebo to BF-200 ALA | 26 | |
| Overall Study | NOT COMPLETED | BF-200 ALA | 1 | |
| Overall Study | NOT COMPLETED | Placebo to BF-200 ALA | 6 |
Source ClinicalTrials.gov
Adverse events28
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 pain | General disorders | BF-200 ALA | 53 | 55 | 162 |
| other | Application site pain | General disorders | Placebo to BF-200 ALA | 16 | 32 | 30 |
| other | Application site erythema | General disorders | BF-200 ALA | 51 | 55 | 76 |
| other | Application site erythema | General disorders | Placebo to BF-200 ALA | 11 | 32 | 14 |
| other | Application site pruritus | General disorders | BF-200 ALA | 21 | 55 | 25 |
| other | Application site pruritus | General disorders | Placebo to BF-200 ALA | 9 | 32 | 10 |
| other | Application site scab | General disorders | BF-200 ALA | 20 | 55 | 26 |
| other | Application site scab | General disorders | Placebo to BF-200 ALA | 1 | 32 | 1 |
| other | Application site exfoliation | General disorders | BF-200 ALA | 17 | 55 | 21 |
| other | Application site exfoliation | General disorders | Placebo to BF-200 ALA | 1 | 32 | 1 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BF-200 ALA | ||
| Total, all-cause mortality | Placebo to BF-200 ALA | ||
| Total, other adverse events | BF-200 ALA | 55 | 55 |
| Total, other adverse events | Placebo to BF-200 ALA | 22 | 32 |
| Total, serious adverse events | BF-200 ALA | 2 | 55 |
| Total, serious adverse events | Placebo to BF-200 ALA | 0 | 32 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39666443 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| BF-200 ALA vs Placebo to BF-200 ALA: serious adverse events |
Source Trial comparisons
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
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