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| Name | Class |
|---|---|
| BioPhotas | INDUSTRY |
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The purpose of this study is to evaluate the effect of light therapy on wound healing after laser treatment.
This study sets out to evaluate the effect of a combination of near infrared (830 nm) red (633 nm) and blue (465nm) light-emitting diode (LED) therapy on wound healing after laser application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LED treatment | Experimental | LED treatment with Celluma POD device after laser test area |
|
| Control | No Intervention | No treatment after laser test area |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celluma POD | Device | A blue and near infrared handheld LED device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days to Healing | The primary endpoint of this study is time and days to complete healing of the treatment sites. Clinical grading shall be by blinded assessment. | Assessed from Day 0 to Day 55, up to 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level | A secondary outcome measure will be post-treatment pain on a 11-point Lickert scale from 0-10. Higher scores mean a worse outcome. | Assessed from Day 0 to Day 13, up to 14 days |
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Inclusion Criteria:
Adults aged 18 years or older with no active cutaneous disease on bilateral ventral biceps, close to the axilla.
Subjects shall have given written informed consent for both the LED therapy and for clinical photography.
Exclusion Criteria:
Patients will be excluded if any of the exclusion criteria applies
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Kelly, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCI Beckman Laser Institute and Medical Clinic | Irvine | California | 92697 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | LED Treatment | LED treatment with Celluma POD device after laser test area Celluma POD: A blue and near infrared handheld LED device |
| FG001 | Control | No treatment after laser test area |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
32 subjects were screened and consented. 7 subjects were unable to participate due to scheduling difficulties. They never participated in any study procedures. 25 subjects participated in the study as both experimental and control groups.
| ID | Title | Description |
|---|---|---|
| BG000 | LED Treatment | LED treatment with Celluma POD device after laser test area Celluma POD: A blue and near infrared handheld LED device |
| BG001 | Control | No treatment after laser test area |
| 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 | Days to Healing | The primary endpoint of this study is time and days to complete healing of the treatment sites. Clinical grading shall be by blinded assessment. | Posted | Number | participants | Assessed from Day 0 to Day 55, up to 56 days |
|
55 days post-treatment
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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 | LED Treatment | LED treatment with Celluma POD device after laser test area Celluma POD: A blue and near infrared handheld LED device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristen Kelly, Professor and Chair, Dept. of Dermatology | University of California, Irvine | 949-824-5515 | kmkelly@hs.uci.edu |
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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 | Nov 29, 2023 | Jan 21, 2025 | Prot_SAP_000.pdf |
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This is a split-person study design where each participant has one arm with the intervention and the other arm that is control.
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| BG002 | Total | Total of all reporting groups |
| wound area |
|
| Age |
| wound area |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Units | wound area | wound area |
|
| Race (NIH/OMB) | Count of Units | wound area | wound area |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Pain Level | A secondary outcome measure will be post-treatment pain on a 11-point Lickert scale from 0-10. Higher scores mean a worse outcome. | Posted | Count of Participants | Participants | Assessed from Day 0 to Day 13, up to 14 days |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Control | No treatment after laser test area | 0 | 25 | 0 | 25 | 0 | 25 |
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| Reported itch on days 9 and 13, resolved by day 13 |
|