Fractional CO2 Treatment of Acne Scars in Asians

Mahidol University12 enrolled

Overview

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%).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acne Scar, Wrinkle

Interventions

Fractional CO2 LaserDEVICE

the treatment settings: 1. Pulse duration : 5 to 7ms depending on skin reaction 2. Spot Density: 49 MTZ/cm2 (Low density) 3. Power: 15 W = (75 - 105) mJ/MTZ

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Thailand

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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