Actinic KeratosisPhase 1NCT05060237
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
A Phase 1 study testing BF-200 ALA and red light LED lamp in people with Actinic Keratosis and Keratosis, Actinic, run by Biofrontera Bioscience GmbH at 9 sites in United States.
Trial summary
The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the expanded treatment field using 3 tubes of BF-200 ALA 10% gel (Ameluz®) in conjunction with the BF-RhodoLED® XL PDT lamp. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis, Keratosis, Actinic, Keratosis
- What is being tested?
- BF-200 ALA and red light LED lamp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Dec 2021to 20 Apr 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness and ability of subjects to provide informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures.
- Subjects with mild to severe clinically confirmed AK lesions (according to Olsen) on the face and/or scalp. In case of severe AK lesions, a biopsy must be taken for confirmation of diagnosis. At least 8 mild to moderate AK lesions with a diameter of ≥4 mm must be present in the treatment field. The treatment field (continuous or in several patches) totaling about 60 cm2 must be located within one effective illumination area. The AK lesions should be clearly distinguishable, without restrictions on the distance between lesions. Lesions should have a minimal distance of 1 cm between the lesion margin and the border of the treatment field.
- All sexes, ≥18 years of age.
- Willingness and ability to comply with study procedures, particularly willingness to receive a PDT session and to undergo 2 mm punch biopsy/biopsies in case of severe AK lesion(s) at the screening visit.
- Subjects with good general health or with clinically stable medical conditions will be permitted to be included in the study. Subjects with clinically stable medical conditions will be permitted for inclusion into the study if not using prohibited medication.
- Willingness to stop the use of moisturizers and any other non-medical topical treatments within the treatment field at least 24 h prior to the visits.
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- Acceptance to abstain from extensive sunbathing and the use of a solarium or tanning beds during the study.
- For female subjects with reproductive potential: Negative serum pregnancy test.
- For female subjects with reproductive potential: Effective contraception at screening visit and throughout the study.
Who cannot join
- Any known history of hypersensitivity to ALA, porphyrins or excipients of BF-200 ALA.
- History of soy or peanut allergy.
- Subjects with sunburn or other possible confounding skin conditions (e.g. wounds, irritations, bleeding or skin infections) inside or in close proximity (<10 cm distance) to the treatment field.
- Clinically significant (CS) medical conditions making implementation of the protocol or interpretation of the study results difficult or impairing subject's safety such as:
- Presence of photodermatoses or porphyria
- Metastatic tumor or tumor with high probability of metastasis
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- Infiltrating skin neoplasia (suspected or known)
- Unstable cardiovascular disease (New York Heart Association class III, IV)
- Unstable hematologic (including myelodysplastic syndrome), hepatic, renal, neurologic, or endocrine condition
- Unstable collagen-vascular condition
- Unstable gastrointestinal condition
- Immunosuppressive condition
- Presence of clinically significant inherited or acquired coagulation defect
- Clinical diagnosis of atopic dermatitis, Bowen's disease, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, other malignant or benign tumors inside or in close proximity (<10 cm distance) to the treatment field.
- Presence of strong artificial pigmentation (e.g. tattoos) or any other abnormality that may impact lesion assessment or light penetration in the treatment field.
- Any physical therapy such as cryosurgery, laser therapy, electrodessication, microdermabrasion, surgical removal of lesions, curettage, or treatment with chemical peels such as trichloroacetic acid inside or in close proximity (<10 cm distance) to the treatment field within 4 weeks prior to screening.
- Any of the topical treatments defined below within the designated periods prior to screening:
- Topical treatment with ALA or ALA esters (e.g. methyl aminolevulinic acid (MAL)) or an investigational drug in- and outside the treatment field within 8 weeks.
- Topical treatment with immunosuppressive, cytostatic or cytotoxic drugs inside or in close proximity (<10 cm distance) to the treatment field within 8 weeks.
- Start of topical administration of a medication with hypericin or other drugs with phototoxic or photoallergic potential inside or in close proximity (<10 cm distance) to the treatment field within 4 weeks. Subjects may, however, be eligible if such medication was applied for more than 4 weeks prior to screening without evidence of an actual phototoxic/photoallergic reaction.
- Any use of the systemic treatments within the designated periods prior to screening:
- Cytostatic or cytotoxic drugs within 6 months.
- Immunosuppressive therapies or use of ALA or ALA esters (e.g. MAL) within 12 weeks.
- Drugs known to have major organ toxicity within 8 weeks or an investigational drug.
- Interferon or glucocorticosteroids within 6 weeks.
- Start of intake of medication with hypericin or systemically acting drugs with phototoxic or photoallergic potential within 8 weeks prior to screening. Subjects may, however, be eligible if such medication was taken in for more than 8 weeks prior to the screening visit without evidence of an actual phototoxic/photoallergic reaction.
- Breast feeding women.
- Suspicion of drug or alcohol abuse.
- Subjects unlikely to comply with protocol, e.g. inability to return for visits, unlikely to complete the study, or inappropriate in the opinion of the investigator.
- A member of study site staff or sponsor staff directly involved in the conduct of the protocol or a close relative thereof.
- Simultaneous participation in another clinical study.
- Dosing day exclusion criteria:
- At Visit 2 (baseline, PDT-1)
- Subjects with sunburn or other possibly confounding skin conditions (e.g. wounds, irritations, bleeding or skin infections) inside or in close proximity (<10 cm distance) to the treatment field.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Dermatology Practice
Greenwood Village, Colorado, 80111
Austin Institute for Clinical Research
Houston, Texas, 77056
Laser and Skin Surgery Center of Indiana
Indianapolis, Indiana, 46260
Austin Institute for Clinical Research Inc.
Pflugerville, Texas, 78660
Medical Dermatology Specialists
Phoenix, Arizona, 85006
Alliance Dermatology & Mohs Center
Phoenix, Arizona, 85032
Skin Search of Rochester, Inc
Rochester, New York, 14623
Rochester Dermatologic Surgery
Victor, New York, 14564
About this study
Official title: A Non-randomized, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BF-200 ALA (Ameluz®) in the Expanded Field-directed Treatment of Actinic Keratosis on the Face and Scalp With Photodynamic Therapy (PDT)
The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the expanded treatment field using 3 tubes of BF-200 ALA 10% gel (Ameluz®) in conjunction with the BF-RhodoLED® XL PDT lamp.
- Conditions
- Actinic Keratosis, Keratosis, Actinic, Keratosis
- Being tested
- BF-200 ALA and red light LED lamp
- Keywords
- Actinic keratosis, Photodynamic therapy, 5-aminolevulinic acid, Photosensitizing Agents, Dermatologic Agents, Precancerous condition, Skin Disease
- Medical subject headings
- Keratosis, Actinic, Keratosis, Precancerous Conditions, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BF-200 ALA and red light LED lampCombination product
Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT):
Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²), followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing.
| Study group | Role | What they receive |
|---|---|---|
| BF-200 ALA | Experimental | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
One single photodynamic therapy (PDT). Receives: Combination Product: BF-200 ALA and red light LED lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs).
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.
Measured: Through study completion, on average 6 weeks
Duration of TEAEs Including the Breakdown of Severity Category (Mild, Moderate, Severe).
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.
Measured: From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)
Assessment of New Lesions (AK, NMSC Such as BCC, SCC or Bowens Disease, and Melanoma) if They Occur Inside the Treatment Field
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.
Measured: From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)
Assessment of New Lesions (AK, NMSC, and Melanoma) if They Occur Around the Treatment Field at a Distance of <10 cm
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.
Measured: From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)
Application Site Skin Reactions During and Post PDT, Assessed by the Investigator
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
Measured: From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)
Application Site Discomfort During and Post PDT, Reported by the Subjects
Application site discomfort categories: burning, hyperaesthesia, pain, paraesthesia, pruritus, stinging, warmth, other; severity of AE: mild, moderate or severe
Measured: From treatment day (day 1, Visit 2) up to Visit 5 (approx. 28 days post treatment)
Application Site Pain During 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".
Measured: At treatment day (day 1, Visit 2) after end of illumination
Changes in Blood Pressure (Systolic and Diastolic)
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.
Measured: 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
Changes in Pulse Rate
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.
Measured: 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
Changes in Body Temperature
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.
Measured: 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
Investigation of Clinical Chemistry Parameters
Findings which differ from reference range and are considered to be clinically significant are to be reported. Clinical chemistry parameters include glucose, creatinine, total bilirubin, aspartate aminotransferase (AST), alanineaminotransferase (ALT), lactate dehydrogenase (LDH), alkalinephosphatase (AP),gamma glutamyl transferase (GGT), potassium, sodium, calcium, total protein, albumin.
Measured: At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment)
Investigation of Hematology Parameters
Findings which differ from reference range and are considered to be clinically significant are to be reported. Hematology parameters include hemoglobin, hematocrit, red blood cell count, leukocyte count (white blood cells(WBC)) with differential count (neutrophils, lymphocytes, monocytes, eosinophils, basophils), and platelet count.
Measured: At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment)
Investigation of Urinalysis Parameters
Findings which differ from reference range and are considered to be clinically significant (CS) are to be reported
Measured: At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment)
Physical Examination of Head, Neck, Skin, Lymph Nodes, Thorax Including Heart and Lungs, Abdomen, and Musculoskeletal, Peripheral Vascular and Nervous System Status
Abnormal findings, considered to be clinically significant (CS), are to be reported
Measured: At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment)
Memory Tests
Including picture- and question-based memory tasks; abnormal findings that are considered clinically significant will be documented
Measured: At screening (Visit 1, up to 14 days before treatment) and at Visit 2 (treatment day 1)
Neurological Investigations
Including investigation of pupils (equality), coordination (finger-nose test), gait (balance), and sensitivity (cheeks, arms, legs); abnormal findings that are considered clinically significant (CS) will be documented
Measured: At screening (Visit 1, up to 14 days before treatment) and at Visit 2 (treatment day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Dec 2021
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biofrontera Bioscience GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Schlesinger, MD, Principal investigator, Clinical Research Center of the Carolinas, 1364 Ashley River Road, Charleston, SC 29407, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060237
- Sponsor's protocol ID
- ALA-AK-CT018
- Status last verified
- Oct 2024
- First submitted
- 7 Sep 2021
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BF-200 ALA (Ameluz®) in the Expanded Field-directed Treatment of Actinic Keratosis on the Face and Scalp With Photodynamic Therapy (PDT)
- ClinicalTrials.gov ID
- NCT05060237
- Acronym / sponsor ID
- ALA-AK-CT018
- Conditions
- Actinic Keratosis, Keratosis, Actinic, Keratosis
- Keywords
- Actinic keratosis, Photodynamic therapy, 5-aminolevulinic acid, Photosensitizing Agents, Dermatologic Agents, Precancerous condition, Skin Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Biofrontera Bioscience GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the expanded treatment field using 3 tubes of BF-200 ALA 10% gel (Ameluz®) in conjunction with the BF-RhodoLED® XL PDT lamp.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BF-200 ALA | Experimental | Combination Product: BF-200 ALA and red light LED lampTopical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). One single photodynamic therapy (PDT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willingness and ability of subjects to provide informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures.
- Subjects with mild to severe clinically confirmed AK lesions (according to Olsen) on the face and/or scalp. In case of severe AK lesions, a biopsy must be taken for confirmation of diagnosis. At least 8 mild to moderate AK lesions with a diameter of ≥4 mm must be present in the treatment field. The treatment field (continuous or in several patches) totaling about 60 cm2 must be located within one effective illumination area. The AK lesions should be clearly distinguishable, without restrictions on the distance between lesions. Lesions should have a minimal distance of 1 cm between the lesion margin and the border of the treatment field.
- All sexes, ≥18 years of age.
- Willingness and ability to comply with study procedures, particularly willingness to receive a PDT session and to undergo 2 mm punch biopsy/biopsies in case of severe AK lesion(s) at the screening visit.
- Subjects with good general health or with clinically stable medical conditions will be permitted to be included in the study. Subjects with clinically stable medical conditions will be permitted for inclusion into the study if not using prohibited medication.
Key exclusion criteria (34 listed)
- Any known history of hypersensitivity to ALA, porphyrins or excipients of BF-200 ALA.
- History of soy or peanut allergy.
- Subjects with sunburn or other possible confounding skin conditions (e.g. wounds, irritations, bleeding or skin infections) inside or in close proximity (<10 cm distance) to the treatment field.
- Clinically significant (CS) medical conditions making implementation of the protocol or interpretation of the study results difficult or impairing subject's safety such as:
- Clinical diagnosis of atopic dermatitis, Bowen's disease, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, other malignant or benign tumors inside or in close proximity (<10 cm distance) to the treatment field.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BF-200 ALA and red light LED lampPhotodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²), followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing. | Combination product | BF-200 ALA |
Primary outcome
Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs).
Time frame: 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.
Duration of TEAEs Including the Breakdown of Severity Category (Mild, Moderate, Severe).
Time frame: 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.
Assessment of New Lesions (AK, NMSC Such as BCC, SCC or Bowens Disease, and Melanoma) if They Occur Inside the Treatment Field
Time frame: 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.
Assessment of New Lesions (AK, NMSC, and Melanoma) if They Occur Around the Treatment Field at a Distance of <10 cm
Time frame: 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.
Application Site Skin Reactions During and Post PDT, Assessed by the Investigator
Time frame: 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
Application Site Discomfort During and Post PDT, Reported by the Subjects
Time frame: 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
Application Site Pain During Illumination
Time frame: 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".
Changes in Blood Pressure (Systolic and Diastolic)
Time frame: 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.
Changes in Pulse Rate
Time frame: 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.
Changes in Body Temperature
Time frame: 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.
Investigation of Clinical Chemistry Parameters
Time frame: At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment)
Findings which differ from reference range and are considered to be clinically significant are to be reported. Clinical chemistry parameters include glucose, creatinine, total bilirubin, aspartate aminotransferase (AST), alanineaminotransferase (ALT), lactate dehydrogenase (LDH), alkalinephosphatase (AP),gamma glutamyl transferase (GGT), potassium, sodium, calcium, total protein, albumin.
Investigation of Hematology Parameters
Time frame: At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment)
Findings which differ from reference range and are considered to be clinically significant are to be reported. Hematology parameters include hemoglobin, hematocrit, red blood cell count, leukocyte count (white blood cells(WBC)) with differential count (neutrophils, lymphocytes, monocytes, eosinophils, basophils), and platelet count.
Investigation of Urinalysis Parameters
Time frame: At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment)
Findings which differ from reference range and are considered to be clinically significant (CS) are to be reported
Physical Examination of Head, Neck, Skin, Lymph Nodes, Thorax Including Heart and Lungs, Abdomen, and Musculoskeletal, Peripheral Vascular and Nervous System Status
Time frame: At screening (Visit 1, up to 14 days before treatment) and at Visit 5 (approx. 28 days post treatment)
Abnormal findings, considered to be clinically significant (CS), are to be reported
Memory Tests
Time frame: At screening (Visit 1, up to 14 days before treatment) and at Visit 2 (treatment day 1)
Including picture- and question-based memory tasks; abnormal findings that are considered clinically significant will be documented
Neurological Investigations
Time frame: At screening (Visit 1, up to 14 days before treatment) and at Visit 2 (treatment day 1)
Including investigation of pupils (equality), coordination (finger-nose test), gait (balance), and sensitivity (cheeks, arms, legs); abnormal findings that are considered clinically significant (CS) will be documented
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Schlesinger, MD principal investigator
Clinical Research Center of the Carolinas, 1364 Ashley River Road, Charleston, SC 29407, USA
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BF-200 ALA and red light LED lamp in people with Actinic Keratosis and Keratosis, Actinic, run by Biofrontera Bioscience GmbH at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and Severity of Adverse Events (AEs), Serious AEs (SAEs), and Treatment Emergent Adverse Events (TEAEs). (time frame: Through study completion, on average 6 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.