The objective of this study is to investigate the efficacy and side effects of a fractional CO2 laser for treatment of acne scar in Asians.
Study Type:
Interventional
Study Design:
Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Clinical Quality Assurance Study: Fractional CO2 Treatment of Acne Scars in Asians
Primary Outcome Measures:
- by the clinical investigator and graded into one of six categories: worse, no effect, slightly better, fair, good, and excellent. The results shall be reported. [ Time Frame: Follow-up 1 and 3 months after the last treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The outcome and degree of satisfaction based on the before photo is evaluated by the patients themselves [ Time Frame: Follow-up 1 and 3 months after the last treatment ] [ Designated as safety issue: Yes ]
Estimated Enrollment:
12
Study Start Date:
July 2008
Estimated Study Completion Date:
December 2008
Estimated Primary Completion Date:
December 2008 (Final data collection date for primary outcome measure)
|
1: Experimental
Fractional CO2 laser resurfacing
|
Device: Fractional CO2 Laser
the treatment settings:
- Pulse duration : 5 to 7ms depending on skin reaction
- Spot Density: 49 MTZ/cm2 (Low density)
- Power: 15 W = (75 - 105) mJ/MTZ
|
- The objective of this study is to investigate the efficacy and side effects of a fractional CO2 laser for treatment of acne scar in Asians.
Study hypothesis
- Reduction in acne scars based on blinded evaluation of before photos and the one and three month follow-up photos after four full face Ellipse Juvia with low density treatments with a fluency of 90-105 mJ/MTZ is statistically significant (5%).
- The direct clinical blinded evaluated reduction in acne scars based on before photos and the patient in life, by the one and three month follow-up is statistically significant (5%)
- Reduction in fine lines based on blinded evaluation of before photos and the one and three month follow-up photos after four full face Ellipse Juvia with low density treatments with a fluency of 90-105 mJ/MTZ is statistically significant (5%).
- The direct clinical blinded evaluated reduction in fine lines based on before photos and the patient in life, by the one and three month follow-up is statistically significant (5%).
- Reduction in pigmented disorders based on blinded evaluation of before photos and the one and three month follow-up photos after four full face Ellipse Juvia with low density treatments with a fluency of 90-105 mJ/MTZ is statistically significant (5%).
- The direct clinical blinded evaluated reduction in pigmented disorders based on before photos and the patient in life, by the one and three month follow-up is statistically significant (5%).
- Improvements in skin texture and pore size based on blinded evaluation of before photos and the one and three month follow-up photos after four full face Ellipse Juvia with low density treatments with a fluency of 90-105 mJ/MTZ is statistically significant (5%).
- The direct clinical blinded evaluated reduction in skin texture and pore size based on before photos and the patient in life, by the one and three month follow-up is statistically significant (5%).