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
• Interventions: Device: Intense pulse light

• 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

Arm && Interventions

Group	Intervention	Description
combined IPL/fractional Er:YAG laser treatment site	Intense pulse light	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.

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