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Fractional CO2 Treatment of Acne Scars in Asians

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00748462
First received: July 1, 2008
Last updated: September 5, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Acne Scar, Wrinkle
 Device: Fractional CO2 Laser
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Quality Assurance Study: Fractional CO2 Treatment of Acne Scars in Asians

Resource links provided by NLM:

MedlinePlus related topics: Acne Scars
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: July 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fractional CO2 laser resurfacing
 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

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%).
  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748462

Contacts
Contact: Woraphong Manuskiatti, M.D. 66-2419-9922 siwmn@mahidol.ac.th
Contact: Rungsima Wanitphakdeedecha, M.D. 66-2419-9922 sirwn@mahidol.ac.th

Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Woraphong Manuskiatti, M.D.     66-2419-9922     siwmn@mahidol.ac.th    
Principal Investigator: Woraphong Manuskiatti, M.D.            
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Woraphong Manuskiatti, M.D. Department of Dermatology, Siriraj Hospital
  More Information

Publications:

Responsible Party: Ellipse A/S, Factulty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT00748462     History of Changes
Other Study ID Numbers: SiEC 145/2551 (EC4), 1CIP7978- A02
Study First Received: July 1, 2008
Last Updated: September 5, 2008
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Acne scar, Wrinkle, Pigmentation, Fractional CO2 laser

Additional relevant MeSH terms:
Acne Vulgaris
Cicatrix
Acneiform Eruptions
Skin Diseases
 Facial Dermatoses
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013