Fractional CO2 Treatment of Acne Scars in Asians

Study Overview
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Brief Summary
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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
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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%).

Official Title
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Clinical Quality Assurance Study: Fractional CO2 Treatment of Acne Scars in Asians

Conditions
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Acne Scar, Wrinkle

Intervention / Treatment
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* Device: Fractional CO2 Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fractional CO2 laser resurfacing | Device: Fractional CO2 Laser<br>* 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<br>* Other names: Juvia (trade mark)Fractional CO2 Laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne scar, Wrinkle, Pigmentation, Fractional CO2 laser