- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00748462
Fractional CO2 Treatment of Acne Scars in Asians (CO2)
January 24, 2014 updated by: Woraphong Manuskiatti, M.D., Mahidol University
Clinical Quality Assurance Study: Fractional CO2 Treatment of Acne Scars in Asians
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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%).
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital, Mahidol University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Fractional CO2 laser resurfacing
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the treatment settings:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: Follow-up 1 and 3 months after the last treatment
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Follow-up 1 and 3 months after the last treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Follow-up 1 and 3 months after the last treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Woraphong Manuskiatti, M.D., Department of Dermatology, Siriraj Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. doi: 10.1016/s0733-8635(05)70286-2.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
July 1, 2008
First Submitted That Met QC Criteria
September 5, 2008
First Posted (Estimate)
September 8, 2008
Study Record Updates
Last Update Posted (Estimate)
January 28, 2014
Last Update Submitted That Met QC Criteria
January 24, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SiEC 145/2551 (EC4)
- 1CIP7978- A02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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