Fractional CO2 Treatment of Acne Scars in Asians
- Conditions
- Acne Scar, Wrinkle
- Interventions
- Device: Fractional CO2 Laser
- Registration Number
- NCT00748462
- Lead Sponsor
- Mahidol University
- Brief Summary
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.
- Detailed Description
* 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%).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Numbers of volunteers: 10 healthy men and women
- Aged at least 30 year old
- Skin type: 1 - 4
- Degree of suntan: None - light
- Skin condition: visible acne scars
- Fitzpatrick skin types 5-6.
- Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind.
- Patients with skin diseases associated with Koebner phenomena.
- Patients who have used Botox or filler injection to the periorbital or perioral regions 12 months prior or during the study.
- Patients who have used topical retinoids, AHA under prescription or Vitamin C, 3 months prior to or during the study.
- Patients who are pregnant or who wish to become pregnant and lactating women.
- Patients who have been exposed to sun within 2 week from date of treatment.
- Patients prone to hypertrophic scars or keloids
- Patients who have previously undergone laser resurfacing may not be suitable for yet another procedure.
- Patients undergoing oral retinoid therapy for acne in the past 6 months.
- Patients who suffer from any serious medical condition, including diabetes, bleeding diathesis, delayed wound healing or prednisolone intake.
- Patients with wound infections (herpes, other) on the day of treatment.
- Patients with moderate and severe inflammatory acne, Immunosuppressed patients, History of vitiligo.
- Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Fractional CO2 Laser Fractional CO2 laser resurfacing
- Primary Outcome Measures
Name Time Method 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. Follow-up 1 and 3 months after the last treatment
- Secondary Outcome Measures
Name Time Method The outcome and degree of satisfaction based on the before photo is evaluated by the patients themselves Follow-up 1 and 3 months after the last treatment
Trial Locations
- Locations (1)
Faculty of Medicine Siriraj Hospital, Mahidol University
🇹ðŸ‡Bangkok, Thailand