NCT04722705

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

January 20, 2021

Last Update Submit

January 22, 2021

Conditions

Intense Pulsed LightErbium-yttrium Aluminum Garnet LaserScar Prevention

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Total Vancouver Scar scale

    4 weeks

  • Total Vancouver Scar scale

    8 weeks

  • Total Vancouver Scar scale

    20 weeks

  • Erythema index

    4 weeks

  • Erythema index

    8 weeks

  • +4 more secondary outcomes

Study Arms (3)

combined IPL/fractional Er:YAG laser treatment site

EXPERIMENTAL

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 laserDevice: Intense pulse light

fractional Er:YAG laser treatment alone site

ACTIVE COMPARATOR

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

untreated control site

NO INTERVENTION

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.

Interventions

fractional Er:YAG laserDEVICE

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.

Also known as: Matrixell, Medro corp., Seoul, Korea
combined IPL/fractional Er:YAG laser treatment sitefractional Er:YAG laser treatment alone site
Intense pulse lightDEVICE

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.

Also known as: IPL (Ellipse Flex, DDD, Hoersholm, Denmark)
combined IPL/fractional Er:YAG laser treatment site

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of postoperative scars on the abdomen
  • scars were symmetrical shaped in a line of 3cm or more

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

RECRUITING

Study Officials

  • Bo Young Chung, M.D., PhD

    Department of Dermatology, Kangnam Sacred Heart Hospital

    STUDY CHAIR

Central Study Contacts

Bo Young Chung, M.D., PhD

CONTACT

+82-10-8940-4343victoryby@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 25, 2021

Study Start

January 6, 2020

Primary Completion

November 14, 2021

Study Completion

November 14, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)