Trial · NCT03573401
Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).
NCT03573401, Phase 3, Active not recruiting, Biofrontera Inc.; results first posted 2025-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT). Trials, record NCT03573401. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03573401
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).
- NCT number
- NCT03573401
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 187 participants, actual
- Lead sponsor
- Biofrontera Inc.
- Conditions
- Superficial Basal Cell Carcinoma
- Interventions
- Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT), Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
- First posted
- 2018-06-29
- Last updated
- 2026-01-14
- Results first posted
- 2025-04-29
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Clinical and Histological Response of the Subject's Main Target Lesion as Assessed 12 Weeks After the Start of the Last PDT Cycle That Included Treatment of the Main Target Lesion. | 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion | Each subject had one Main Target Lesion. The composite clinical and histological response rate of the subjects' Main Target Lesions is the percentage of subjects with a clinically and histologically cleared Main Target lesion 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion (Visit 5 or Visit 8). |
| Secondary | Main Target Lesion Clinical Response Rate (According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle | 12 weeks after the start of the last PDT cycle | 1\. Key secondary endpoint: Percentage of Main Target Lesions with complete clinical clearance (i.e. according to clinical assessment only) 12 weeks after the start of the last PDT cycle. |
| Secondary | Main Target Lesion Histological Response Rate (According to Histological Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle | 12 weeks after the start of the last PDT cycle | 2\. Key secondary endpoint: Percentage of Main Target Lesions with complete histological clearance (i.e. according to histological assessment only) 12 weeks after the start of the last PDT cycle. |
| Secondary | Subject Complete Clinical Response (Complete Clearance of All Target Lesions According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle. | 12 weeks after the start of the last PDT cycle | 3\. Key secondary endpoint: Percentage of subjects with complete clinical clearance of all Target Lesions (i.e. according to clinical assessment only) 12 weeks after the start of the last PDT cycle. |
| Secondary | Subject Complete Response (Clinically and Histologically Cleared Main Target Lesion (See Above) and Complete Clinical Remission of All Additional Target Lesions) Assessed 12 Weeks After the Start of the Last PDT Cycle. | 12 weeks after the start of the last PDT cycle | 4\. Key secondary endpoint: Percentage of subjects with complete clinical and histological clearance of the Main Target Lesion and complete clinical clearance of all Additional Target Lesions 12 weeks after the start of the last PDT cycle |
| Secondary | Lesion Complete Clinical Response Rate Per Treatment Arm (Complete Clearance of Individual Lesions (Main and Additional Target Lesions)) According to Clinical Assessment Only, Assessed 12 Weeks After the Start of the Last PDT Cycle. | 12 weeks after the start of the last PDT cycle | Further secondary endpoint: Percentage of Individual Target Lesions that are completely clinically cleared per treatment arm 12 weeks after the start of the last PDT cycle. |
| Secondary | Main Target Lesion Complete Response (Clinically and Histologically Cleared) Assessed 12 Weeks After PDT-1. | 12 weeks after PDT-1 | Further secondary endpoint: Percentage of Main Target Lesions that are clinically and histologically cleared 12 weeks after PDT-1. |
| Secondary | Main Target Lesion Clinical Response (According to Clinical Assessment Only) Assessed 12 Weeks After PDT-1. | 12 weeks after PDT-1 | Further secondary endpoint: Percentage of Main Target Lesions that are clinically cleared 12 weeks after PDT-1. |
| Secondary | Main Target Lesion Histological Response (According to Histological Assessment Only) Assessed 12 Weeks After PDT-1. | 12 weeks after PDT-1 | Further secondary endpoint: Percentage of Main Target Lesions that are histologically cleared 12 weeks after PDT-1. |
| Secondary | Lesion Complete Clinical Response Rate Per Treatment Arm (Complete Clearance of Individual Lesions (Main and Additional Target Lesions)) According to Clinical Assessment Only, Assessed 12 Weeks After PDT-1. | 12 weeks after PDT-1 | Further secondary endpoint: Percentage of Individual Target Lesions that are completely clinically cleared per treatment arm 12 weeks after PDT-1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Clinical and Histological Response of the Subject's Main Target Lesion as Assessed 12 Weeks After the Start of the Last PDT Cycle That Included Treatment of the Main Target Lesion. | 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion | Full analysis set | percentage of subjects | NUMBER |
| SECONDARY | Main Target Lesion Clinical Response Rate (According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle | 12 weeks after the start of the last PDT cycle | Full analysis set | percentage of Main Target Lesions | NUMBER |
| SECONDARY | Main Target Lesion Histological Response Rate (According to Histological Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle | 12 weeks after the start of the last PDT cycle | Full analysis set | percentage of Main Target Lesions | NUMBER |
| SECONDARY | Subject Complete Clinical Response (Complete Clearance of All Target Lesions According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle. | 12 weeks after the start of the last PDT cycle | Full analysis set | percentage of subjects | NUMBER |
| SECONDARY | Subject Complete Response (Clinically and Histologically Cleared Main Target Lesion (See Above) and Complete Clinical Remission of All Additional Target Lesions) Assessed 12 Weeks After the Start of the Last PDT Cycle. | 12 weeks after the start of the last PDT cycle | Full analysis set | percentage of subjects | NUMBER |
| SECONDARY | Lesion Complete Clinical Response Rate Per Treatment Arm (Complete Clearance of Individual Lesions (Main and Additional Target Lesions)) According to Clinical Assessment Only, Assessed 12 Weeks After the Start of the Last PDT Cycle. | 12 weeks after the start of the last PDT cycle | Full analysis set | percentage of target lesions | NUMBER |
| SECONDARY | Main Target Lesion Complete Response (Clinically and Histologically Cleared) Assessed 12 Weeks After PDT-1. | 12 weeks after PDT-1 | Full analysis set | percentage of Main Target Lesions | NUMBER |
| SECONDARY | Main Target Lesion Clinical Response (According to Clinical Assessment Only) Assessed 12 Weeks After PDT-1. | 12 weeks after PDT-1 | Full analysis set | percentage of Main Target Lesions | NUMBER |
| SECONDARY | Main Target Lesion Histological Response (According to Histological Assessment Only) Assessed 12 Weeks After PDT-1. | 12 weeks after PDT-1 | Full analysis set | percentage of Main Target Lesions | NUMBER |
| SECONDARY | Lesion Complete Clinical Response Rate Per Treatment Arm (Complete Clearance of Individual Lesions (Main and Additional Target Lesions)) According to Clinical Assessment Only, Assessed 12 Weeks After PDT-1. | 12 weeks after PDT-1 | Full analysis set | percentage of target lesions | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Clinical and Histological Response of the Subject's Main Target Lesion as Assessed 12 Weeks After the Start of the Last PDT Cycle That Included Treatment of the Main Target Lesion. | BF-200 ALA | 65.5 | percentage of subjects | ||
| Composite Clinical and Histological Response of the Subject's Main Target Lesion as Assessed 12 Weeks After the Start of the Last PDT Cycle That Included Treatment of the Main Target Lesion. | Vehicle | 4.8 | percentage of subjects | ||
| Main Target Lesion Clinical Response Rate (According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle | BF-200 ALA | 83.4 | percentage of Main Target Lesions | ||
| Main Target Lesion Clinical Response Rate (According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle | Vehicle | 21.4 | percentage of Main Target Lesions | ||
| Main Target Lesion Histological Response Rate (According to Histological Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle | BF-200 ALA | 75.9 | percentage of Main Target Lesions | ||
| Main Target Lesion Histological Response Rate (According to Histological Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle | Vehicle | 19.0 | percentage of Main Target Lesions | ||
| Subject Complete Clinical Response (Complete Clearance of All Target Lesions According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle. | BF-200 ALA | 82.1 | percentage of subjects | ||
| Subject Complete Clinical Response (Complete Clearance of All Target Lesions According to Clinical Assessment Only) Assessed 12 Weeks After the Start of the Last PDT Cycle. | Vehicle | 21.4 | percentage of subjects | ||
Subject Complete Response (Clinically and Histologically Cleared Main Target Lesion (See Above) and Complete Clinical Remission of All Additional Target Lesions) Assessed 12 Weeks After the Start of the Last PDT Cycle. | BF-200 ALA | 64.1 | percentage of subjects | ||
Subject Complete Response (Clinically and Histologically Cleared Main Target Lesion (See Above) and Complete Clinical Remission of All Additional Target Lesions) Assessed 12 Weeks After the Start of the Last PDT Cycle. | Vehicle | 4.8 | percentage of subjects |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 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 | 145 | |
| Overall Study | STARTED | Vehicle | 42 | |
| Overall Study | COMPLETED | BF-200 ALA | 141 | |
| Overall Study | COMPLETED | Vehicle | 41 | |
| Overall Study | NOT COMPLETED | BF-200 ALA | 4 | |
| Overall Study | NOT COMPLETED | Vehicle | 1 |
Source ClinicalTrials.gov
Adverse events48
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 discharge | General disorders | BF-200 ALA | 4 | 145 | 6 |
| other | Application site discharge | General disorders | Vehicle | 2 | 42 | 2 |
| other | Application site discolouration | General disorders | BF-200 ALA | 13 | 145 | 15 |
| other | Application site discolouration | General disorders | Vehicle | 1 | 42 | 1 |
| other | Application site erosion | General disorders | BF-200 ALA | 7 | 145 | 8 |
| other | Application site erosion | General disorders | Vehicle | 3 | 42 | 6 |
| other | Application site erythema | General disorders | BF-200 ALA | 100 | 145 | 228 |
| other | Application site erythema | General disorders | Vehicle | 16 | 42 | 48 |
| other | Application site exfoliation | General disorders | BF-200 ALA | 25 | 145 | 30 |
| other | Application site exfoliation | General disorders | Vehicle | 7 | 42 | 13 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 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 | 145 |
| Total, all-cause mortality | Vehicle | 0 | 42 |
| Total, other adverse events | BF-200 ALA | 145 | 145 |
| Total, other adverse events | Vehicle | 35 | 42 |
| Total, serious adverse events | BF-200 ALA | 3 | 145 |
| Total, serious adverse events | Vehicle | 2 | 42 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40846240 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BF-200 ALA vs Vehicle: deaths from any cause | Trial comparisons |
| BF-200 ALA vs Vehicle: 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.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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