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

Not Applicable

• Conditions: Intense Pulsed Light; Erbium-yttrium Aluminum Garnet Laser; Scar Prevention

• Registration Number: NCT04722705
• Lead Sponsor: Hallym University Kangnam Sacred Heart Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-06
• Status Verified: 2021-01
• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-20
• Last Update Submitted: 2021-01-22
• Study First Posted: 2021-01-25
• Last Update Posted: 2021-01-26
• Primary Completion: 2021-11-14
• Study Completion: 2021-11-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Observer Scar Assessment Scale	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.

Secondary Outcome Measures

Name	Time	Method
Total Vancouver Scar scale	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.
Erythema index	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.
Melanin index	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.

Trial Locations

Locations (1)

Kangnam Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of