Fractional CO2 Treatment of Acne Scars in Asians

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Woraphong Manuskiatti, M.D., Mahidol University
ClinicalTrials.gov Identifier:
NCT00748462
First received: July 1, 2008
Last updated: January 24, 2014
Last verified: January 2014
  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:


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 ]

Enrollment: 12
Study Start Date: July 2008
Study Completion Date: December 2008
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

Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Woraphong Manuskiatti, M.D. Department of Dermatology, Siriraj Hospital
  More Information

Publications:
Responsible Party: Woraphong Manuskiatti, M.D., Professor, 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: January 24, 2014
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 April 16, 2014