Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention
Efficacy of Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bo Young Chung, M.D., PhD
- Phone Number: +82-10-8940-4343
- Email: victoryby@naver.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 07441
- Recruiting
- KangNam Sacred Heart Hospital
-
Contact:
- Jin Cheol Kim, MD
- Phone Number: +82-10-4350-9110
- Email: aiekfne@naver.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of postoperative scars on the abdomen
- scars were symmetrical shaped in a line of 3cm or more
Exclusion Criteria:
- uncontrolled systemic or chronic disease
- hypersensitive to the ingredients
- a history of other laser treatments within the past 6 months
- pregnancy
- lactation
- Recent sun exposure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: combined IPL/fractional Er:YAG laser treatment site
At baseline, three lesions were randomized to IPL / fractional Er:YAG laser combination therapy site. Topical anesthetic cream was applied to the scar 30 minutes before laser treatment. The same dermatologist performed all laser treatments including IPL and 2,940 nm Er:YAG fractional laser. The face was cooled after treatment with gauze soaked in ice water. The laser treatment was conducted total three sessions, immediately at suture removal, 4 weeks after suture removal and 8 weeks after suture removal. The evaluation of scar site was conducted 3 months later after last treatment. |
At baseline, three lesions were randomized. Topical anesthetic cream was applied to the scar 30 minutes before laser treatment. The same dermatologist performed 2,940 nm Er:YAG fractional laser. (long pulse mode, 1500mJ, 2Hz, 2 pass) The face was cooled after treatment with gauze soaked in ice water. The laser treatment was conducted total three sessions, immediately at suture removal, 4 weeks after suture removal and 8 weeks after suture removal. The evaluation of scar site was conducted 3 months later after last treatment.
Other Names:
At baseline, three lesions were randomized. Topical anesthetic cream was applied to the scar 30 minutes before laser treatment. The same dermatologist performed IPL. (irridation energy: 12.5J/cm2, pulse duration: 10ms, 1pass) The face was cooled after treatment with gauze soaked in ice water. The laser treatment was conducted total three sessions, immediately at suture removal, 4 weeks after suture removal and 8 weeks after suture removal. The evaluation of scar site was conducted 3 months later after last treatment.
Other Names:
|
|
Active Comparator: fractional Er:YAG laser treatment alone site
At baseline, three lesions were randomized to fractional Er:YAG laser combination therapy site. Topical anesthetic cream was applied to the scar 30 minutes before laser treatment. The same dermatologist performed 2,940 nm Er:YAG fractional laser. The face was cooled after treatment with gauze soaked in ice water. The laser treatment was conducted total three sessions, immediately at suture removal, 4 weeks after suture removal and 8 weeks after suture removal. The evaluation of scar site was conducted 3 months later after last treatment. |
At baseline, three lesions were randomized. Topical anesthetic cream was applied to the scar 30 minutes before laser treatment. The same dermatologist performed 2,940 nm Er:YAG fractional laser. (long pulse mode, 1500mJ, 2Hz, 2 pass) The face was cooled after treatment with gauze soaked in ice water. The laser treatment was conducted total three sessions, immediately at suture removal, 4 weeks after suture removal and 8 weeks after suture removal. The evaluation of scar site was conducted 3 months later after last treatment.
Other Names:
|
|
No Intervention: untreated control site
At baseline, three lesions were randomized to untreated control site.
Topical anesthetic cream was applied to the scar 30 minutes before laser treatment.
The evaluation of scar site was conducted 3 months later after last treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Observer Scar Assessment Scale
Time Frame: 4 weeks
|
The POSAS observer consists of following 6 items: vascularity, pigmentation, thickness, surface area, relief, pliability.
Each item was evaluated on a scale from 1 (normal skin) to 10 (worst scar).
Finally, the POSAS total score was calculated as the sum of six items, ranging from 6 to 60.
|
4 weeks
|
|
Patient Observer Scar Assessment Scale
Time Frame: 8 weeks
|
The POSAS observer consists of following 6 items: vascularity, pigmentation, thickness, surface area, relief, pliability.
Each item was evaluated on a scale from 1 (normal skin) to 10 (worst scar).
Finally, the POSAS total score was calculated as the sum of six items, ranging from 6 to 60.
|
8 weeks
|
|
Patient Observer Scar Assessment Scale
Time Frame: 20 weeks
|
The POSAS observer consists of following 6 items: vascularity, pigmentation, thickness, surface area, relief, pliability.
Each item was evaluated on a scale from 1 (normal skin) to 10 (worst scar).
Finally, the POSAS total score was calculated as the sum of six items, ranging from 6 to 60.
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Vancouver Scar scale
Time Frame: 4 weeks
|
The VSS consists of 4 following components: vascularity, pigmentation, height ranging from 0 to 3, and pliability from 0 to 5. Score zero means the normal skin, while maximum scores indicate the worst scar.
|
4 weeks
|
|
Total Vancouver Scar scale
Time Frame: 8 weeks
|
The VSS consists of 4 following components: vascularity, pigmentation, height ranging from 0 to 3, and pliability from 0 to 5. Score zero means the normal skin, while maximum scores indicate the worst scar.
|
8 weeks
|
|
Total Vancouver Scar scale
Time Frame: 20 weeks
|
The VSS consists of 4 following components: vascularity, pigmentation, height ranging from 0 to 3, and pliability from 0 to 5. Score zero means the normal skin, while maximum scores indicate the worst scar.
|
20 weeks
|
|
Erythema index
Time Frame: 4 weeks
|
The indexes were measured by placing Spectrophotometer (Cortex Technology, Had- sund, Denmark) directly on the skin lesions for two minutes in the room with constant temperature (20~24 degree Celsius) and humidity (28~38 percent). This measurement was performed to determine erythema. |
4 weeks
|
|
Erythema index
Time Frame: 8 weeks
|
The indexes were measured by placing Spectrophotometer (Cortex Technology, Had- sund, Denmark) directly on the skin lesions for two minutes in the room with constant temperature (20~24 degree Celsius) and humidity (28~38 percent). This measurement was performed to determine erythema. |
8 weeks
|
|
Erythema index
Time Frame: 20 weeks
|
The indexes were measured by placing Spectrophotometer (Cortex Technology, Had- sund, Denmark) directly on the skin lesions for two minutes in the room with constant temperature (20~24 degree Celsius) and humidity (28~38 percent). This measurement was performed to determine erythema. |
20 weeks
|
|
Melanin index
Time Frame: 4 weeks
|
The indexes were measured by placing Spectrophotometer (Cortex Technology, Had- sund, Denmark) directly on the skin lesions for two minutes in the room with constant temperature (20~24 degree Celsius) and humidity (28~38 percent). This measurement was performed to determine pigmentation. |
4 weeks
|
|
Melanin index
Time Frame: 8 weeks
|
The indexes were measured by placing Spectrophotometer (Cortex Technology, Had- sund, Denmark) directly on the skin lesions for two minutes in the room with constant temperature (20~24 degree Celsius) and humidity (28~38 percent). This measurement was performed to determine pigmentation. |
8 weeks
|
|
Melanin index
Time Frame: 20 weeks
|
The indexes were measured by placing Spectrophotometer (Cortex Technology, Had- sund, Denmark) directly on the skin lesions for two minutes in the room with constant temperature (20~24 degree Celsius) and humidity (28~38 percent). This measurement was performed to determine pigmentation. |
20 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Bo Young Chung, M.D., PhD, Department of Dermatology, Kangnam Sacred Heart Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-11-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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