Fractional CO2 Treatment of Acne Scars in Asians - Full Text View

Sponsored by:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00748462

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 IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Clinical Quality Assurance Study: Fractional CO2 Treatment of Acne Scars in Asians

Resource links provided by NLM:

MedlinePlus related topics: Acne Scars

Drug Information available for: Carbon dioxide

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
1: Experimental Fractional CO2 laser resurfacing	Device: Fractional CO2 Laser 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

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:

Fitzpatrick RE. Laser resurfacing today and the "cookbook" approach: a recipe for disaster? A comment. J Cosmet Dermatol. 2005 Dec;4(4):298-9. No abstract available.

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.

Alster TS, Lupton JR. Erbium:YAG cutaneous laser resurfacing. Dermatol Clin. 2001 Jul;19(3):453-66. Review.

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.

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

Keywords provided by Mahidol University:

Acne scar, Wrinkle, Pigmentation, Fractional CO2 laser

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Facies
Skin Diseases

Sebaceous Gland Diseases
Acne Vulgaris
Cicatrix

Additional relevant MeSH terms:

Facial Dermatoses
Skin Diseases
Acneiform Eruptions

Sebaceous Gland Diseases
Acne Vulgaris
Cicatrix

ClinicalTrials.gov processed this record on July 06, 2009