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Completed

NCT Number: NCT00748462

Fractional CO2 Treatment of Acne Scars 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.

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Key information

Conditions

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

  • 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%).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fractional CO2 Laser

Device

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

Other names: Juvia (trade mark)Fractional CO2 Laser

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Acronym: CO2

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 8, 2008
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.