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Fractional CO2 Treatment of Acne Scars in Asians

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00748462
Acronym
CO2
Enrollment
12
Registered
2008-09-08
Start date
2008-07-31
Completion date
2008-12-31
Last updated
2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Scar, Wrinkle

Keywords

Acne scar, Wrinkle, Pigmentation, Fractional CO2 laser

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%).

Interventions

DEVICEFractional CO2 Laser

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

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
The outcome and degree of satisfaction based on the before photo is evaluated by the patients themselvesFollow-up 1 and 3 months after the last treatment

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026