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Fractional CO2 Treatment of Acne Scars in Asians (CO2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00748462
First Posted: September 8, 2008
Last Update Posted: January 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Woraphong Manuskiatti, M.D., Mahidol University
July 1, 2008
September 8, 2008
January 28, 2014
July 2008
December 2008   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00748462 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Fractional CO2 Treatment of Acne Scars in Asians
Clinical Quality Assurance Study: 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.
  • 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%).
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acne Scar, Wrinkle
Device: Fractional 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
Other Name: Juvia (trade mark)Fractional CO2 Laser
Experimental: 1
Fractional CO2 laser resurfacing
Intervention: Device: Fractional CO2 Laser

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2008
December 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
25 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT00748462
SiEC 145/2551 (EC4)
1CIP7978- A02
Yes
Not Provided
Not Provided
Woraphong Manuskiatti, M.D., Mahidol University
Mahidol University
Not Provided
Principal Investigator: Woraphong Manuskiatti, M.D. Department of Dermatology, Siriraj Hospital
Mahidol University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP