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

Scar Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04722705
• Other study ID #: 2019-11-007
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: November 14, 2021

Study information

• Verified date: January 2021
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: Bo Young Chung, M.D., PhD
• Phone: +82-10-8940-4343
• Email: victoryby[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 14, 2021
• Est. primary completion date: November 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Erbium-yttrium Aluminum Garnet Laser
• Intense Pulsed Light
• Scar Prevention

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Kangnam Sacred Heart Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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