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

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).

Study Overview

• Status: Recruiting
• Conditions: Intense Pulsed Light; Erbium-yttrium Aluminum Garnet Laser; Scar Prevention
• Intervention / Treatment: Device: fractional Er:YAG laser; Device: Intense pulse light

• Study Type: Interventional
• Enrollment (Anticipated): 30
• 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

• Korea, Republic of
  • 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: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

3

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.	Device: fractional Er:YAG laser; 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: Matrixell, Medro corp., Seoul, Korea; Device: Intense pulse light; 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: IPL (Ellipse Flex, DDD, Hoersholm, Denmark)
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.	Device: fractional Er:YAG laser; 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: Matrixell, Medro corp., Seoul, Korea
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	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

Collaborators and Investigators

• Sponsor: Hallym University Kangnam Sacred Heart Hospital
• 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): January 6, 2020
• Primary Completion (Anticipated): November 14, 2021
• Study Completion (Anticipated): November 14, 2021

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

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)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No