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Fractional CO2 Treatment of Acne Scars in Asians (CO2)

Primary Purpose

Acne Scar, Wrinkle

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Fractional CO2 Laser
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scar, Wrinkle focused on measuring Acne scar, Wrinkle, Pigmentation, Fractional CO2 laser

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Fractional CO2 laser resurfacing

Outcomes

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.

Secondary Outcome Measures

The outcome and degree of satisfaction based on the before photo is evaluated by the patients themselves

Full Information

First Posted
July 1, 2008
Last Updated
January 24, 2014
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT00748462
Brief Title
Fractional CO2 Treatment of Acne Scars in Asians
Acronym
CO2
Official Title
Clinical Quality Assurance Study: Fractional CO2 Treatment of Acne Scars in Asians
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scar, Wrinkle
Keywords
Acne scar, Wrinkle, Pigmentation, Fractional CO2 laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Fractional CO2 laser resurfacing
Intervention Type
Device
Intervention Name(s)
Fractional CO2 Laser
Other Intervention Name(s)
Juvia (trade mark)Fractional CO2 Laser
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woraphong Manuskiatti, M.D.
Organizational Affiliation
Department of Dermatology, Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
17168879
Citation
Fitzpatrick RE. Laser resurfacing today and the "cookbook" approach: a recipe for disaster? A comment. J Cosmet Dermatol. 2005 Dec;4(4):298-9; author reply 299-300. doi: 10.1111/j.1473-2165.2005.00208.x. No abstract available.
Results Reference
background
PubMed Identifier
8629842
Citation
Fitzpatrick RE, Goldman MP, Satur NM, Tope WD. Pulsed carbon dioxide laser resurfacing of photo-aged facial skin. Arch Dermatol. 1996 Apr;132(4):395-402.
Results Reference
background
PubMed Identifier
11599402
Citation
Alster TS, Lupton JR. Erbium:YAG cutaneous laser resurfacing. Dermatol Clin. 2001 Jul;19(3):453-66. doi: 10.1016/s0733-8635(05)70286-2.
Results Reference
background
PubMed Identifier
15216537
Citation
Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
Results Reference
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Fractional CO2 Treatment of Acne Scars in Asians

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