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

NCT ID: NCT04722705

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2021-11-14

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).

Detailed Description

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Conditions

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Intense Pulsed Light Erbium-yttrium Aluminum Garnet Laser Scar Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

fractional Er:YAG laser

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

fractional Er:YAG laser

Intervention Type DEVICE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Matrixell, Medro corp., Seoul, Korea IPL (Ellipse Flex, DDD, Hoersholm, Denmark)

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Kangnam Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bo Young Chung

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Young Chung, M.D., PhD

Role: STUDY_CHAIR

Department of Dermatology, Kangnam Sacred Heart Hospital

Locations

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Kangnam Sacred Heart Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Bo Young Chung, M.D., PhD

Role: CONTACT

+82-10-8940-4343

Facility Contacts

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Jin Cheol Kim, MD

Role: primary

+82-10-4350-9110

Other Identifiers

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2019-11-007

Identifier Type: -

Identifier Source: org_study_id

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