Fractional CO2 Treatment of Acne Scars in Asians

Mahidol University

Status and phase

Completed

Phase 4

Conditions

Acne Scar, Wrinkle

Treatments

Device: Fractional CO2 Laser

Study type

Interventional

Funder types

Other

Identifiers

NCT00748462

1CIP7978- A02

SiEC 145/2551 (EC4)

Details and patient eligibility

About

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.

Full 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%).

Enrollment

12 patients

Sex

All

Ages

25 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.