Acne Scar, Wrinkle Clinical Trial
Official title:
Clinical Quality Assurance Study: Fractional CO2 Treatment of Acne Scars in Asians
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.
- 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
1. 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%).
2. 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%)
3. 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%).
4. 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%).
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%).
6. 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%).
7. 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%).
8. 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%).
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment