Trial Outcomes & Findings for Fractional Resurfacing Device for Treatment of Acne Scarring (NCT NCT00585286)
NCT ID: NCT00585286
Last Updated: 2014-01-15
Results Overview
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).
COMPLETED
PHASE1/PHASE2
15 participants
Baseline, 1 month and 3 months post-treatment
2014-01-15
Participant Flow
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.
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.
Participant milestones
| Measure |
Fractional Carbon Dioxide Laser System
Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional carbon dioxide laser system.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Fractional Carbon Dioxide Laser System
Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional carbon dioxide laser system.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Fractional Resurfacing Device for Treatment of Acne Scarring
Baseline characteristics by cohort
| Measure |
Fractional CO2 Laser System
n=15 Participants
Thirty healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month and 3 months post-treatmentPopulation: 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.
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).
Outcome measures
| Measure |
Fractional CO2 Laser System
n=14 Participants
Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
|
|---|---|
|
Overall Improvement of Acne Scarring
Month 1
|
2.26 units on a scale
Standard Deviation 1.15
|
|
Overall Improvement of Acne Scarring
Month 3
|
1.91 units on a scale
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: Baseline, 1 month and 3 months post-treatmentPopulation: 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.
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).
Outcome measures
| Measure |
Fractional CO2 Laser System
n=14 Participants
Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
|
|---|---|
|
Average Improvement in Surface Texture
Month 1
|
1.94 units on a scale
Standard Deviation 1.16
|
|
Average Improvement in Surface Texture
Month 3
|
2.09 units on a scale
Standard Deviation 0.85
|
PRIMARY outcome
Timeframe: Baseline, 1 month and 3 months post-treatmentPopulation: 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.
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).
Outcome measures
| Measure |
Fractional CO2 Laser System
n=14 Participants
Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
|
|---|---|
|
Degree of Atrophy
Month 1
|
1.68 units on a scale
Standard Deviation 1.11
|
|
Degree of Atrophy
Month 3
|
1.65 units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Fractional CO2 Laser System
n=14 Participants
Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
|
|---|---|
|
Pain Tolerance
|
5.67 units on a scale
Standard Deviation 0.833
|
Adverse Events
Fractional CO2 Laser System
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christopher Zachary, FRCP, MBBS/Prinicipal Investigator
University of California, Irvine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place