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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
| Biofrontera Inc. | INDUSTRY |
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The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while reducing or eliminating the pain that patients sometimes experience during conventional PDT treatment. The main questions it aims to answer are:
Participants will be randomly assigned to one of three treatment regimens, which will determine the length of time that the topical medication will incubate on the face before red light exposure in PDT treatments. The incubation period will be either 10 minutes, 20 minutes, or 60 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source |
|
| Regimen B | Experimental | Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source |
|
| Regimen C | Experimental | Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical aminolevulinate (10% ALA gel) | Drug | 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Efficacy Based on Participant AK Lesion Clearance | To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol. This will be measured by Clinical Efficacy, which will be based on the AK lesion counts and lesion clearance rate after two treatments. | Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6) |
| Differences in Pain Level Reported Throughout Exposure to Red Light | Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS scale 0= no pain, 10 = intolerable pain) | Pain measured during illumination with red light (during a 10 min period) at Visit 1 (Day 3) and at Visit 3 (Month 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Survey as Measured by Treatment Outcome Score | Treatment score on a scale of 0 to 5, where 0 indicates extremely dissatisfied and 5 indicates extremely satisfied. | 6 months |
| Patient Satisfaction Survey as Measured by Cosmetic Outcome Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward V Maytin, M.D. Ph.D. | Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40581198 | Derived | Johnson JS, Hanna J, Nowacki AS, Anand S, Shen AS, Maytin EV. Painless PDT using 10% aminolevulinate gel and red light: A pilot clinical trial of short-contact protocols to reduce discomfort during illumination. Photodiagnosis Photodyn Ther. 2025 Aug;54:104698. doi: 10.1016/j.pdpdt.2025.104698. Epub 2025 Jun 26. |
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Data will be available 12/2024
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A total of 10 subjects are enrolled for each of the study arms A, B, and C.
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| ID | Title | Description |
|---|---|---|
| FG000 | Regimen A | Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 |
| FG001 | Regimen B | Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 |
| FG002 | Regimen C | Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Regimen A | Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Efficacy Based on Participant AK Lesion Clearance | To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol. This will be measured by Clinical Efficacy, which will be based on the AK lesion counts and lesion clearance rate after two treatments. | Posted | Number | percentage of AK lesions | Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6) | Lesions | Lesions |
|
Serious adverse events that occur from signing of informed consent through 30 days after the last dose of treatment, up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regimen A | Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward V Maytin | Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center | (216) 445-6676 | maytine@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2023 | Jun 10, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 5, 2024 | Jun 10, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Red light illumination | Device | Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 |
|
|
Cosmetic score on a scale of 0 to 5, where 0 indicates extremely dissatisfied and 5 indicates extremely satisfied. |
| At month 6 |
| Number of Participant Reported Adverse Events and Side Effects | Overall AE Profile and Safety of treatment will be measured using an Adverse Events- Patients' side effects log and Investigator assessment. | Up to 6 days (Day 6) after Visit 1 |
| BG001 |
| Regimen B |
Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 |
| BG002 | Regimen C | Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| History of skin cancer | Count of Participants | Participants |
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| AK lesions | Mean | Standard Deviation | Lesions |
|
| AKs previously | Count of Participants | Participants |
|
| OG001 | Regimen B | Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 |
| OG002 | Regimen C | Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 |
|
|
| Primary | Differences in Pain Level Reported Throughout Exposure to Red Light | Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS scale 0= no pain, 10 = intolerable pain) | Posted | Mean | Standard Error | score on a scale | Pain measured during illumination with red light (during a 10 min period) at Visit 1 (Day 3) and at Visit 3 (Month 2) |
|
|
|
| Secondary | Patient Satisfaction Survey as Measured by Treatment Outcome Score | Treatment score on a scale of 0 to 5, where 0 indicates extremely dissatisfied and 5 indicates extremely satisfied. | Posted | Number | percentage of patients | 6 months |
|
|
|
| Secondary | Patient Satisfaction Survey as Measured by Cosmetic Outcome Score | Cosmetic score on a scale of 0 to 5, where 0 indicates extremely dissatisfied and 5 indicates extremely satisfied. | Posted | Number | percentage of patients | At month 6 |
|
|
|
| Secondary | Number of Participant Reported Adverse Events and Side Effects | Overall AE Profile and Safety of treatment will be measured using an Adverse Events- Patients' side effects log and Investigator assessment. | Posted | Number | Number of events | Up to 6 days (Day 6) after Visit 1 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Regimen B | Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Regimen C | Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2 | 0 | 10 | 0 | 10 | 1 | 10 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
|
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| Percentages of patients giving a score of 3 |
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| Percentages of patients giving a score of 2 |
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| Percentages of patients giving a score of 1 |
|
|
| Percentage of participants giving a score of 3 |
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| Percentage of participants giving a score of 2 |
|
| Percentage of participants giving a score of 1 |
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| Title | Measurements |
|---|---|
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