Trial · NCT05060237
Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp
NCT05060237, Phase 1, Completed, Biofrontera Bioscience GmbH; results first posted 2024-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp. Trials, record NCT05060237. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05060237
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp
- NCT number
- NCT05060237
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 112 participants, actual
- Lead sponsor
- Biofrontera Bioscience GmbH
- Conditions
- Actinic Keratosis, Keratosis, Actinic, Keratosis
- Interventions
- BF-200 ALA and red light LED lamp
- First posted
- 2021-09-29
- Last updated
- 2024-10-17
- Results first posted
- 2024-10-17
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | Through study completion, on average 6 weeks | TEAEs are defined as all AEs with onset or worsening after treatment with IMP up to Visit 5 (Final Visit). TEAEs are considered being related to IMP or medical device, if causal relationship between IMP or medical device and the TEAE is at least possible or relationship assessment is missing. If an AE occurs in different treatment areas (face, scalp, face and scalp), it is reported separately for each treatment area. Thus, some AEs are counted more than once. |
| Primary | Duration of TEAEs Including the Breakdown of Severity Category (Mild, Moderate, Severe). | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | The duration of TEAEs related to IMP and/or medical device which occurred in at least two subjects and with complete start and stop dates was analyzed. In addition, the proportion of the duration by severity was analyzed. Duration of severity per subject and preferred term is calculated in days counting all days and all episodes of one severity category together. Calculation is done referring to all subjects with occurrence of respective preferred term. If a severity category of a preferred term does not occur in a subject, the duration of this category is set to 0. If an AE occurs in different treatment areas, it is reported separately for each treatment area (face, scalp, face and scalp). Thus, some AEs are counted more than once for the analysis. |
| Primary | Assessment of New Lesions (AK, NMSC Such as BCC, SCC or Bowens Disease, and Melanoma) if They Occur Inside the Treatment Field | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | Assessed were newly occuring lesions of actinic keratosis (AK), non-melanoma skin cancer (NMSC) such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC) or Bowens disease, and melanoma inside the treatment field. Cumulative number of lesions is reported. |
| Primary | Assessment of New Lesions (AK, NMSC, and Melanoma) if They Occur Around the Treatment Field at a Distance of <10 cm | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | Assessed were newly occuring lesions of actinic keratosis (AK), non-melanoma skin cancer (NMSC) such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC) or Bowens disease, and melanoma inside the treatment field. Cumulative number of lesions is reported. |
| Primary | Application Site Skin Reactions During and Post PDT, Assessed by the Investigator | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | Application site skin reaction categories: discharge, erosion, erythema, exfoliation, fissure, induration, oedema, scabbing, skin flaking, ulceration, vesicles, other; severity of AE: mild, moderate or severe |
| Primary | Application Site Discomfort During and Post PDT, Reported by the Subjects | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | Application site discomfort categories: burning, hyperaesthesia, pain, paraesthesia, pruritus, stinging, warmth, other; severity of AE: mild, moderate or severe |
| Primary | Application Site Pain During Illumination | At treatment day (day 1, Visit 2) after end of illumination | Assessed by the subjects using an 11-point numeric rating scale (NRS), where a score of 0 means "no pain" and a score of 10 means "worst imaginable pain". |
| Primary | Changes in Blood Pressure (Systolic and Diastolic) | All visits through study completion after Visit 1: Visit 2, baseline, treatment day; Visit 3, approx. 7 days post treatment; Visit 4, approx.14 days post treatment; Visit 5, approx. 28 days post treatment | Change from baseline is presented. The first measurement at Visit 2 (arrival at site) was considered as baseline value for all following measurements. Blood pressure was measured in mmHg. At Visit 2, photodynamic therapy was performed. |
| Primary | Changes in Pulse Rate | All visits through study completion after Visit 1: Visit 2, baseline, treatment day; Visit 3, approx. 7 days post treatment; Visit 4, approx.14 days post treatment; Visit 5, approx. 28 days post treatment | Change from baseline is presented. The first measurement at Visit 2 (arrival at the site) was considered as baseline value for all following measurements. Pulse rate was measures in beats/min. At Visit 2, photodynamic therapy was performed. |
| Primary | Changes in Body Temperature | All visits through study completion after Visit 1: Visit 2, baseline, treatment day; Visit 3, approx. 7 days post treatment; Visit 4, approx.14 days post treatment; Visit 5, approx. 28 days post treatment | Change from baseline is presented. The first measurement at Visit 2 (arrival at site) was considered as baseline value for all following measurements. Body temperature was measured in °F and was converted to °C in the electronic Case Report Form. At Visit 2, photodynamic therapy was performed. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | Through study completion, on average 6 weeks | Number of events | NUMBER | |
| PRIMARY | Duration of TEAEs Including the Breakdown of Severity Category (Mild, Moderate, Severe). | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | days | MEAN | |
| PRIMARY | Assessment of New Lesions (AK, NMSC Such as BCC, SCC or Bowens Disease, and Melanoma) if They Occur Inside the Treatment Field | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | Number of lesions | NUMBER | |
| PRIMARY | Assessment of New Lesions (AK, NMSC, and Melanoma) if They Occur Around the Treatment Field at a Distance of <10 cm | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | Number of lesions | NUMBER | |
| PRIMARY | Application Site Skin Reactions During and Post PDT, Assessed by the Investigator | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | percentage of partcipants | NUMBER | |
| PRIMARY | Application Site Discomfort During and Post PDT, Reported by the Subjects | From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment) | percentage of participants | NUMBER | |
| PRIMARY | Application Site Pain During Illumination | At treatment day (day 1, Visit 2) after end of illumination | For this study, concomitant medication as pain-relieving measure prior to illumination, concomitant medications given as pain-relieving measures during illumination and physical pain-relieving measures (i.e. interruption of the illumination and/or cooling with an air stream and/or nebulized water) were allowed. Subjects might have received a combination of medications (prior and/or during) and/or measures. | score on a scale | MEAN |
| PRIMARY | Changes in Blood Pressure (Systolic and Diastolic) | All visits through study completion after Visit 1: Visit 2, baseline, treatment day; Visit 3, approx. 7 days post treatment; Visit 4, approx.14 days post treatment; Visit 5, approx. 28 days post treatment | One subject had elevated systolic and diastolic blood pressure at Visit 1 which was considered clinically significant and thus documented as relevant medical history. At Visit 2, blood pressure data was missing for one subject for the timepoint 'within 10 min prior to illumination', and for two subjects for the timepoint '60 min after illumination'. One subject missed Visit 3 and thus had no vital sign measurements at Visit 3. | mmHg | MEAN |
| PRIMARY | Changes in Pulse Rate | All visits through study completion after Visit 1: Visit 2, baseline, treatment day; Visit 3, approx. 7 days post treatment; Visit 4, approx.14 days post treatment; Visit 5, approx. 28 days post treatment | At Visit 2, pulse rate data was missing for one subject for the timepoint 'within 10 min prior to illumination', and for two subjects for the timepoint '60 min after illumination'. One subject missed Visit 3 and thus had no vital sign measurements at Visit 3. | beats per min | MEAN |
| PRIMARY | Changes in Body Temperature | All visits through study completion after Visit 1: Visit 2, baseline, treatment day; Visit 3, approx. 7 days post treatment; Visit 4, approx.14 days post treatment; Visit 5, approx. 28 days post treatment | At Visit 2, body temperature data was missing for one subject for the timepoint 'within 10 min prior to illumination', and for three subjects for the timepoint '60 min after illumination'. One subject missed Visit 3 and thus had no vital sign measurement at Visit 3. For one other subject, no temperature data was available at Visit 3. | °C | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group240
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | Total (BF-200 ALA) | Any AEs | 888 | Number of events | |
| Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | Total (BF-200 ALA) | Any AEs : mild | 563 | Number of events | |
| Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | Total (BF-200 ALA) | Any AEs : moderate | 242 | Number of events | |
| Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | Total (BF-200 ALA) | Any AEs : severe | 83 | Number of events | |
| Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | Total (BF-200 ALA) | Any serious AEs | 0 | Number of events | |
| Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | Total (BF-200 ALA) | Any TEAEs | 871 | Number of events | |
| Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | Total (BF-200 ALA) | Any TEAEs : mild | 546 | Number of events | |
| Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | Total (BF-200 ALA) | Any TEAEs : moderate | 242 | Number of events | |
| Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | Total (BF-200 ALA) | Any TEAEs : severe | 83 | Number of events | |
| Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). | Total (BF-200 ALA) | Any serious TEAEs | 0 | Number of events |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 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 | 112 | |
| Overall Study | Treated on the Face | BF-200 ALA | 40 | |
| Overall Study | Treated on the Scalp | BF-200 ALA | 39 | |
| Overall Study | Treated on the Face and Scalp | BF-200 ALA | 21 | |
| Overall Study | COMPLETED | BF-200 ALA | 100 | |
| Overall Study | NOT COMPLETED | BF-200 ALA | 12 |
Source ClinicalTrials.gov
Adverse events34
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 | Dry eye | Eye disorders | Total (BF-200 ALA) | 3 | 100 | 3 |
| other | Nausea | Gastrointestinal disorders | Total (BF-200 ALA) | 3 | 100 | 3 |
| other | Application site discharge | General disorders | Total (BF-200 ALA) | 4 | 100 | 4 |
| other | Application site discolouration | General disorders | Total (BF-200 ALA) | 6 | 100 | 6 |
| other | Application site discomfort | General disorders | Total (BF-200 ALA) | 11 | 100 | 13 |
| other | Application site dryness | General disorders | Total (BF-200 ALA) | 4 | 100 | 4 |
| other | Application site erosion | General disorders | Total (BF-200 ALA) | 16 | 100 | 18 |
| other | Application site erythema | General disorders | Total (BF-200 ALA) | 86 | 100 | 97 |
| other | Application site exfoliation | General disorders | Total (BF-200 ALA) | 87 | 100 | 117 |
| other | Application site haemorrhage | General disorders | Total (BF-200 ALA) | 10 | 100 | 10 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total (BF-200 ALA) | 0 | 100 |
| Total, other adverse events | Total (BF-200 ALA) | 100 | 100 |
| Total, serious adverse events | Total (BF-200 ALA) | 0 | 100 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05060237
GET https://conductscience.org/api/trials/v1/NCT05060237/results?page=2