Trial · NCT02144077
Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy
NCT02144077, Phase 3, Completed, Biofrontera Bioscience GmbH; results first posted 2019-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy. Trials, record NCT02144077. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02144077
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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 Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy
- NCT number
- NCT02144077
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 281 participants, actual
- Lead sponsor
- Biofrontera Bioscience GmbH
- Conditions
- Basal Cell Carcinoma (BCC)
- Interventions
- BF-200 ALA, methyl-aminolevulinate
- First posted
- 2014-05-21
- Last updated
- 2022-11-03
- Other registries' IDs
- eudract:2013-003241-42
- Results first posted
- 2019-03-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Overall patient complete response rate assessed 12 weeks after the last PDT. The indicated values give the percentage of overall complete responders. An overall complete responder is defined as a patient in whom all treated lesions were cleared. The PP set is the primary analysis set for the analyses of the primary endpoint. |
| Secondary | Lesion Complete Response Assessed 12 Weeks After the Last PDT | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT. The indicated values give percentage of overall completely cleared individual lesions. The PP set is the primary analysis set for the analysis of the secondary endpoint. |
| Secondary | Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT. The PP set is the primary analysis set for the analysis of the secondary endpoint. Please note that the high SD for BF-200 ALA is due to a patient who had increased lesion area fom 63 mm² at baseline to 225 mm² 12 weeks after PDT. This lesion area included a lesion that was later confirmed to be benign skin condition (lentigo solaris). |
| Secondary | Patient Complete Response 12 Weeks After PDT-2 | 12 weeks after PDT-2 (=PDT cycle 1; please note: in this study 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2 (first PDT cycle). The PP set is the primary analysis set for the analysis of the secondary endpoint. |
| Secondary | Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT: * Skin surface * Hyperpigmentation * Hypopigmentation * Mottled or irregular pigmentation * Degree of scarring * Atrophy Cosmetic outcome categories are: * Very good: 12 weeks sum score improved by at least 2 points compared to baseline * Good: 12 weeks sum score improved by 1 point compared to baseline * Satisfactory: 12 weeks sum score identical to the one at baseline * Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline * Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline |
| Secondary | Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT: * Skin surface * Hyperpigmentation * Hypopigmentation * Mottled or irregular pigmentation * Degree of scarring * Atrophy Cosmetic outcome categories are: * Very good: 12 weeks sum score improved by at least 2 points compared to baseline * Good: 12 weeks sum score improved by 1 point compared to baseline * Satisfactory: 12 weeks sum score identical to the one at baseline * Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline * Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline |
| Other | Patient Recurrence Rate (Overall, Cumulative) | 6, 12, 24, 36 and 60 months post-PDT | Patient recurrence rate defined as the number of patients with at least one recurrent lesion during FU after complete clearance 12 weeks after the last PDT |
| Other | Lesion Recurrence Rate (Cumulative) | 6, 12, 24, 36 and 60 months post-PDT | Lesion recurrence rate defined as the number of completely cleared lesions 12 weeks after the last PDT showing recurrence during FU. Overall and subgroup analysis (nodular basal cell carcinoma (nBCC) and superficial basal cell carcinoma (sBCC)). |
Source ClinicalTrials.gov
Outcomes8
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 Rate Assessed 12 Weeks After the Last PDT | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations. | Percentage of Patients | NUMBER |
| SECONDARY | Lesion Complete Response Assessed 12 Weeks After the Last PDT | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations. | Percentage of Individual Lesions | NUMBER |
| SECONDARY | Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations. | Percentage of Change | MEAN |
| SECONDARY | Patient Complete Response 12 Weeks After PDT-2 | 12 weeks after PDT-2 (=PDT cycle 1; please note: in this study 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations. | Percentage of Patients | NUMBER |
| SECONDARY | Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations. | Percentage of Patients | NUMBER |
| SECONDARY | Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1) | 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible). | Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations. | Percentage of Patients | NUMBER |
| OTHER_PRE_SPECIFIED | Patient Recurrence Rate (Overall, Cumulative) | 6, 12, 24, 36 and 60 months post-PDT | Per protocol analysis set in the follow-up (PPS-FUP): all patients of the full analysis set in the follow-up (FAS-UP) without any major protocol deviations | percentage of patients (cumulative) | NUMBER |
| OTHER_PRE_SPECIFIED | Lesion Recurrence Rate (Cumulative) | 6, 12, 24, 36 and 60 months post-PDT | Per protocol analysis in follow-up (PPS-FUP): All lesions in patients in the full analysis set in follow-up (FAS-FUP) without any major protocol deviations | percentage of lesions (cumulative) | NUMBER |
Source ClinicalTrials.gov
Results by group36
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 Rate Assessed 12 Weeks After the Last PDT | BF-200 ALA | 93.4 | 95% Confidence Interval 87.0 to 96.9 | Percentage of Patients | |
| Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT | Methyl-aminolevulinate | 91.8 | 95% Confidence Interval 84.6 to 96.0 | Percentage of Patients | |
| Lesion Complete Response Assessed 12 Weeks After the Last PDT | BF-200 ALA | 94.6 | 95% Confidence Interval 89.3 to 97.5 | Percentage of Individual Lesions | |
| Lesion Complete Response Assessed 12 Weeks After the Last PDT | Methyl-aminolevulinate | 92.9 | 95% Confidence Interval 86.6 to 96.5 | Percentage of Individual Lesions | |
| Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline | BF-200 ALA | -94.5 | Standard Deviation 35.07 | Percentage of Change | |
| Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline | Methyl-aminolevulinate | -97.0 | Standard Deviation 13.37 | Percentage of Change | |
| Patient Complete Response 12 Weeks After PDT-2 | BF-200 ALA | 57.9 | 95% Confidence Interval 48.5 to 66.7 | Percentage of Patients | |
| Patient Complete Response 12 Weeks After PDT-2 | Methyl-aminolevulinate | 56.4 | 95% Confidence Interval 46.6 to 65.7 | Percentage of Patients | |
| Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | BF-200 ALA | Very good | 23.3 | 95% Confidence Interval 16.3 to 32.1 | Percentage of Patients |
| Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline) | Methyl-aminolevulinate | Very good | 14.7 | 95% Confidence Interval 8.9 to 23.0 | Percentage of Patients |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 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 | 138 | |
| Overall Study | STARTED | Methyl-aminolevulinate | 143 | |
| Overall Study | COMPLETED | BF-200 ALA | 128 | |
| Overall Study | COMPLETED | Methyl-aminolevulinate | 132 | |
| Overall Study | NOT COMPLETED | BF-200 ALA | 10 | |
| Overall Study | NOT COMPLETED | Methyl-aminolevulinate | 11 |
Source ClinicalTrials.gov
Adverse events52
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 | 134 | 138 | 718 |
| other | Application site pain | General disorders | Methyl-aminolevulinate | 143 | 143 | 751 |
| other | Application site erythema | General disorders | BF-200 ALA | 120 | 138 | 309 |
| other | Application site erythema | General disorders | Methyl-aminolevulinate | 126 | 143 | 288 |
| other | Application site pruritus | General disorders | BF-200 ALA | 59 | 138 | 91 |
| other | Application site pruritus | General disorders | Methyl-aminolevulinate | 49 | 143 | 84 |
| other | Application site oedema | General disorders | BF-200 ALA | 42 | 138 | 86 |
| other | Application site oedema | General disorders | Methyl-aminolevulinate | 52 | 143 | 108 |
| other | Application site paraesthesia | General disorders | BF-200 ALA | 40 | 138 | 64 |
| other | Application site paraesthesia | General disorders | Methyl-aminolevulinate | 39 | 143 | 65 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BF-200 ALA | 0 | 138 |
| Total, all-cause mortality | Methyl-aminolevulinate | 1 | 143 |
| Total, other adverse events | BF-200 ALA | 138 | 138 |
| Total, other adverse events | Methyl-aminolevulinate | 143 | 143 |
| Total, serious adverse events | BF-200 ALA | 3 | 138 |
| Total, serious adverse events | Methyl-aminolevulinate | 7 | 143 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29432644 | RESULT |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BF-200 ALA vs Methyl-aminolevulinate: deaths from any cause | Trial comparisons |
| BF-200 ALA vs Methyl-aminolevulinate: serious adverse events | 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
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/NCT02144077
GET https://conductscience.org/api/trials/v1/NCT02144077/results?page=2