NCT00748462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

5 months

First QC Date

July 1, 2008

Last Update Submit

January 24, 2014

Conditions

Acne Scar, Wrinkle

Keywords

Acne scar, Wrinkle, Pigmentation, Fractional CO2 laser

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL

Fractional CO2 laser resurfacing

Device: Fractional CO2 Laser

Interventions

Fractional CO2 LaserDEVICE

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

Also known as: Juvia (trade mark)Fractional CO2 Laser
1

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 17168879BACKGROUND

  • 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.

    PMID: 8629842BACKGROUND

  • 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.

    PMID: 11599402BACKGROUND

  • 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.

    PMID: 15216537BACKGROUND

Study Officials

  • Woraphong Manuskiatti, M.D.

    Department of Dermatology, Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2008

First Posted

September 8, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

TH(1)