Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention

Study Overview
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Brief Summary
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The scar site was divided into 3 sites; combined IPL/fractional Er:YAG laser treatment site, fractional Er:YAG laser treatment site and untreated control site. At baseline, three lesions were randomized to IPL / fractional Er:YAG laser combination therapy site, fractional Er:YAG laser treatment alone site, and untreated control site. The laser treatment was conducted total three sessions, immediately at suture removal (baseline), 4 weeks after suture removal and 8 weeks after suture removal. The evaluation of scar site was conducted 3 months later after last treatment (20 weeks after suture removal).

Official Title
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Efficacy of Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention

Conditions
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Intense Pulsed Light, Erbium-yttrium Aluminum Garnet Laser, Scar Prevention

Intervention / Treatment
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* Device: fractional Er:YAG laser
* Device: Intense pulse light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combined IPL/fractional Er:YAG laser treatment site<br>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. | Device: fractional Er:YAG laser<br>* 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.<br>* Other names: Matrixell, Medro corp., Seoul, Korea;Device: Intense pulse light<br>* 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.<br>* Other names: IPL (Ellipse Flex, DDD, Hoersholm, Denmark);|
| Active Comparator: fractional Er:YAG laser treatment alone site<br>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. | Device: fractional Er:YAG laser<br>* 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.<br>* Other names: Matrixell, Medro corp., Seoul, Korea;|
| No Intervention: untreated control site<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Observer Scar Assessment Scale | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |