Fractional CO2 Treatment of Acne Scars in Asians | NCT00748462

Studies
Fractional CO2 Treatment of Acne Scars in Asians

NCT00748462

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jan 28, 2014Estimated

Enrollment

12Actual

Phase

Phase 4

Conditions

Acne Scar, Wrinkle

Interventions

Fractional CO2 Laser

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1CIP7978- A02

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jul 1, 2008

First Submission Date that Met QC Criteria

Sep 5, 2008

First Posted Date

Sep 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2014

Last Update Posted Date

Jan 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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
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%).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Fractional CO2 laser resurfacing	Device: Fractional CO2 Laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		Follow-up 1 and 3 months after the last treatment

Secondary Outcomes

Measure	Description	Time Frame
The outcome and degree of satisfaction based on the before photo is evaluated by the patients themselves		Follow-up 1 and 3 months after the last treatment

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Woraphong Manuskiatti, M.D.	Department of Dermatology, Siriraj Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Siriraj Hospital, Mahidol University		Bangkok		10700	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17168879	Background	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.
8629842	Background	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.