Fractional CO2 Treatment of Acne Scars in Asians

NCT ID: NCT00748462

Last Updated: 2014-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2008-12-31

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%).

Conditions

Acne Scar, Wrinkle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Fractional CO2 laser resurfacing

Group Type: EXPERIMENTAL

Fractional CO2 Laser

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Juvia (trade mark)Fractional CO2 Laser

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Woraphong Manuskiatti, M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Woraphong Manuskiatti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Siriraj Hospital

Locations

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

References

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.

Reference Type: BACKGROUND

PMID: 17168879 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8629842 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11599402 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15216537 (View on PubMed)

Other Identifiers

1CIP7978- A02

Identifier Type: -

Identifier Source: secondary_id

SiEC 145/2551 (EC4)

Identifier Type: -

Identifier Source: org_study_id