Acne, Scar
Conditions
Keywords
acne vulgaris, scarring, laser
Brief summary
The purpose of this research study is to evaluate the safety and effectiveness of a new investigational laser device for treatment of acne scarring, for improvement in the appearance of surface texture and topography (recessed or uneven surfaces).
Detailed description
Thirty subjects between two research locations with an acne scar severity score greater than 4 will receive up to 3 treatments with an FDA IDE and Institutional Review Board approved 10,600nm fractional carbon dioxide laser system. Improvement of acne scarring is evaluated at 1 month and 3 months post-treatment. Post-treatment responses evaluated are immediate erythema, immediate edema, and any other immediate responses. Evaluations are conducted immediate post treatment and one week post-treatment. Key safety data include the severity scoring of post-treatment responses, as well as by photodocumentation. The incidence of side effects such as scarring, pigmentary changes, etc. are evaluated at follow-up visits one and three months post-treatment. Key safety data include the incidence rates and severity scoring of side effects, as well as by photodocumentation
Interventions
DEVICE10,600 nm fractional carbon dioxide laser system
1-3 laser treatments using 20-100 millijoules (mJ) with 100-400 microscopic treatment zones (MTZ)/cm2 per pass and total density of 600-1200 MTZ/cm2
Sponsors
Reliant Technologies, Inc. Mountain View, CA
University of Minnesota
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Have Fitzpatrick skin type I-V. (Type I is blonde/red hair with freckles and Type V are Hispanics and lighter African Americans.) * Are male or female. * Are between 18 and 75 years of age. * Have moderate to severe acne scarring. Acne scarring will be assessed with the Acne Scar Severity Scale. Subjects will be eligible for treatment if the area to be treated is scored as having an Acne Scar Severity Score \> 4 according to the Acne Scar Severity Scale (0-9). * Are able to read, understand, and sign the Informed Consent. * Are willing and able to comply with all follow-up requirements for a minimum of 8 months.
Exclusion criteria
* Have had active localized or systemic infections within 6 months of enrollment * Have compromised ability for wound healing, such as: malnutrition, oral steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid formation (raised and thickened scars), atrophic dermatitis (extreme skin irritation or itchiness) or immunologic abnormalities such as vitiligo (white patches of skin due to loss of pigment) * Have immunocompromised status (inability to resist infection, etc.) * Have been treated with lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 6 months of enrollment * Have taken Accutane within 12 months of enrollment * Are allergic to lidocaine (skin numbing agent) * Are allergic to Valtrex (an anti-viral medication)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Improvement of Acne Scarring | Baseline, 1 month and 3 months post-treatment | Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement). |
| Average Improvement in Surface Texture | Baseline, 1 month and 3 months post-treatment | Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement). |
| Degree of Atrophy | Baseline, 1 month and 3 months post-treatment | Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Tolerance | At treatment visit (up to 3 visits) | The average pain score reported over all three treatments was 5.67, corresponding to moderate pain based on a 10-point scale. The pain score is recorded on a 10-point scale, with 0 being no pain and 10 being worst pain imaginable. All subjects reported that any discomfort associated with the procedure was only during active intervention and resolved immediately post-procedure. Increased pain scores correlated with increased density, but not increased energy. |
Countries
United States
Participant flow
Recruitment details
30 total patients with moderate to severe acne scarring were recruited from 3/2007-5/2008 between two locations. Of these, 15 patients received treatment and 14 patients completed the full course of the study at the University of California, Irvine General Clinical Research Center.
Pre-assignment details
Subjects must not have been treated with other lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 12 months of enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Fractional CO2 Laser System Thirty healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Fractional CO2 Laser System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 36 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Average Improvement in Surface Texture
Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
Time frame: Baseline, 1 month and 3 months post-treatment
Population: Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Fractional CO2 Laser System | Average Improvement in Surface Texture | Month 1 | 1.94 units on a scale | Standard Deviation 1.16 |
| Fractional CO2 Laser System | Average Improvement in Surface Texture | Month 3 | 2.09 units on a scale | Standard Deviation 0.85 |
Primary
Degree of Atrophy
Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
Time frame: Baseline, 1 month and 3 months post-treatment
Population: Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Fractional CO2 Laser System | Degree of Atrophy | Month 3 | 1.65 units on a scale | Standard Deviation 1.14 |
| Fractional CO2 Laser System | Degree of Atrophy | Month 1 | 1.68 units on a scale | Standard Deviation 1.11 |
Primary
Overall Improvement of Acne Scarring
Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
Time frame: Baseline, 1 month and 3 months post-treatment
Population: Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fractional CO2 Laser System | Overall Improvement of Acne Scarring | Month 1 | 2.26 units on a scale | Standard Deviation 1.15 |
| Fractional CO2 Laser System | Overall Improvement of Acne Scarring | Month 3 | 1.91 units on a scale | Standard Deviation 1 |
Secondary
Pain Tolerance
The average pain score reported over all three treatments was 5.67, corresponding to moderate pain based on a 10-point scale. The pain score is recorded on a 10-point scale, with 0 being no pain and 10 being worst pain imaginable. All subjects reported that any discomfort associated with the procedure was only during active intervention and resolved immediately post-procedure. Increased pain scores correlated with increased density, but not increased energy.
Time frame: At treatment visit (up to 3 visits)
Population: Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fractional CO2 Laser System | Pain Tolerance | 5.67 units on a scale | Standard Deviation 0.833 |