Acne Scars - Mixed Atrophic and Hypertrophic
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICE1,550 fracionated photothermolysis laser
All subjects will have one side of their face treated with one laser, and the other side with the other laser.
DEVICE755 picosecond laser
All subjects will have one side of their face treated with one laser, and the other side with the other laser.
Sponsors
David Smart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded Assessors will be reviewing and scoring the photos after the study is completed.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Half Faces to Achieve at Least 25% Improvement in Acne Scarring at Week 24 by Blinded Photo Reviewer | Photos will be taken at week 0, week 4, week 8, and week 24. | Change in Baseline acne scarring compared to week 24 measured by photographic review. Measured by blinded reviewer assessments of photographs. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 22 |
| 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. | 22 |
| 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. | 22 |
| Total | 88 |
Baseline characteristics
| Characteristic | 755 Laser | Total | 1,550 Laser |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 44 Participants | 22 Participants |
| Age, Continuous | 33 years STANDARD_DEVIATION 14.28 | 33 years STANDARD_DEVIATION 14.28 | 33 years STANDARD_DEVIATION 14.28 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 30 Participants | 15 Participants |
| Region of Enrollment United States | 22 participants | 22 participants | 22 participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Male | 12 Participants | 24 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 22 / 22 | 22 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
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.
Time frame: Photos will be taken at week 0, week 4, week 8, and week 24.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| 1,550 Laser | Number of Half Faces to Achieve at Least 25% Improvement in Acne Scarring at Week 24 by Blinded Photo Reviewer | 18 half faces |
| 755 Laser | Number of Half Faces to Achieve at Least 25% Improvement in Acne Scarring at Week 24 by Blinded Photo Reviewer | 17 half faces |