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Clinical Trial comparing the 1,550-nanometer fractionated photothermolysis system laser to the 755 nanometer picosecond laser using a split-face (Right-Left) comparison. Patients will receive laser treatments at week 0, week 4, and week 8. Photographs will be taken prior to laser treatment at each visit, and at the week 24 follow-up visit. Photographs will be reviewed by blinded assessors to rate each side of the face and change from baseline photos.
This is a Clinical Trial comparing the 1,550-nanometer fractionated photothermolysis system laser to the 755 nanometer picosecond laser using a split-face (Right-Left) comparison. Both of these lasers are currently FDA approved for acne scarring.
Approximately 18 subjects, men and women with Fitzpatrick skin types I through V and facial acne scarring of grades III-IV (moderate to severe) will be enrolled. Both sides of the participants' face should have similar amount and severity of acne scarring. Participants will be over 18 years old. Patients have to be otherwise healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity.
Patients have to be overall healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity. Per PI discretion, any serious medical condition that may interfere with the study. In addition, patients who have been taking isotretinoin for a period of 6 months before treatment will be excluded.
Patients will have photographs taken at every visit prior to the laser treatments at week 0, week 4, and week 8. Photographs will also be taken at the week 24 follow-up visit. Photos will then be assessed by qualified blinded reviewers for comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1,550 laser | Active Comparator | This arm is the side of the face treated with the 1550-nanometer Fracionated Photothermolysis laser. |
|
| 755 laser | Active Comparator | This arm is the side of the face treated with the 755-nanometer alexandrite picosecond laser. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1,550 fracionated photothermolysis laser | Device | All subjects will have one side of their face treated with one laser, and the other side with the other laser. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Half Faces to Achieve at Least 25% Improvement in Acne Scarring at Week 24 by Blinded Photo Reviewer | Change in Baseline acne scarring compared to week 24 measured by photographic review. Measured by blinded reviewer assessments of photographs. | Photos will be taken at week 0, week 4, week 8, and week 24. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Smart, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah MidValley Dermatology | Murray | Utah | 84107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1,550 Laser | All subjects on this arm will be treated on this split-faced. This arm is looking at the side of the face treated with the 1,550-nanometer Fracionated Photothermolysis laser. 1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser. |
| FG001 | 755 Laser | All subjects on this arm will be treated on this split-faced. This arm is the side of their face will be treated with the 755-nanometer alexandrite picosecond laser. 1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There were 22 participants total, but each participate received each treatment on half of their face. Therefore, there are 22 participants in each arm, with at total of 22 participants. But there are 44 half faces analyzed in the trial.
| ID | Title | Description |
|---|---|---|
| BG000 | 1,550 Laser | All subjects on this arm will be treated on this split-faced. This arm consists of the half-faces treated with the 1,550-nanometer Fracionated Photothermolysis laser. 1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number of units analyzed was 2 per participant. |
| 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 | Number of Half Faces to Achieve at Least 25% Improvement in Acne Scarring at Week 24 by Blinded Photo Reviewer | Change in Baseline acne scarring compared to week 24 measured by photographic review. Measured by blinded reviewer assessments of photographs. | Posted | Count of Units | half faces | Photos will be taken at week 0, week 4, week 8, and week 24. | half faces | half faces |
|
Adverse events (anticipated and unanticipated) related to study treatments/procedures (based on the judgment of an investigator) were collected from the time of signed consent through week 24.
The adverse events collected for this study differ from the clinicaltrials.gov definition in that the adverse events collected were only considered related to the participant's participation in the research.
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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 | 1,550 Laser | This arm is the side of the face treated with the 1550-nanometer Fracionated Photothermolysis laser. 1,550 fracionated photothermolysis laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Smart, Assistant Professor, Dermatology | University of Utah Dermatology | 8015816465 | david.smart@hsc.utah.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 | Feb 1, 2017 | Jan 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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All subjects will receive half of their faces treated with each laser. Subjects will be randomized to determine which side of the face is treated with each laser.
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Blinded Assessors will be reviewing and scoring the photos after the study is completed.
| 755 picosecond laser | Device | All subjects will have one side of their face treated with one laser, and the other side with the other laser. |
|
| BG001 |
| 755 Laser |
All subjects on this arm will be treated on this split-faced. This arm consists of the half-faces treated with the 755-nanometer alexandrite picosecond laser. 1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser. |
| BG002 | Total | Total of all reporting groups |
| half faces |
|
| Count of Participants |
| Participants |
| Participants |
|
| Age, Continuous | the number of units analyzed was 2 per participant. | Mean | Standard Deviation | years | Participants |
|
| Sex: Female, Male | the number of units analyzed was 2 per participant. | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Each participant received both lasers (one on each side of the face). So there are 22 participants total, however, there are 22 halves of faces on each treatment arm. | the number of units analyzed was 2 per participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | the number of units analyzed was 2 per participant. | Number | participants | Participants |
|
All subjects on this arm will be treated on this split-faced. This arm is the side of their face will be treated with the 755-nanometer alexandrite picosecond laser. 1,550 fracionated photothermolysis laser vs. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser. |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 22 |
| 22 |
| EG001 | 755 Laser | This arm is the side of the face treated with the 755-nanometer alexandrite picosecond laser. 755 picosecond laser: All subjects will have one side of their face treated with one laser, and the other side with the other laser. | 0 | 22 | 0 | 22 | 22 | 22 |
| Transient Crusting or Blistering | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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