Intense Pulsed LightNCT04722705
Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention
A study testing fractional Er:YAG laser and Intense pulse light in people with Intense Pulsed Light and Erbium-yttrium Aluminum Garnet Laser, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intense Pulsed Light, Erbium-yttrium Aluminum Garnet Laser, Scar Prevention
- What is being tested?
- fractional Er:YAG laser and Intense pulse light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jan 2020to 14 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of postoperative scars on the abdomen
- scars were symmetrical shaped in a line of 3cm or more
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kangnam Sacred Heart Hospital
Seoul, 07441
Jin Cheol Kim, MD, +82-10-4350-9110, aiekfne@naver.com
About this study
Official title: Efficacy of Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention
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).
- Being tested
- fractional Er:YAG laser, Intense pulse light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractional Er:YAG laserDevice
Also called Matrixell, Medro corp., Seoul, Korea
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 lightDevice
Also called IPL (Ellipse Flex, DDD, Hoersholm, Denmark)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: fractional Er:YAG laser; Device: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 20 weeks
Secondary outcomes (9)
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.
Measured: 4 weeks
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.
Measured: 8 weeks
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.
Measured: 20 weeks
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.
Measured: 4 weeks
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.
Measured: 8 weeks
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.
Measured: 20 weeks
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.
Measured: 4 weeks
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.
Measured: 8 weeks
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.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start6 Jan 2020
- Primary completion14 Nov 2021 (estimated)
- Study completion14 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intense Pulsed LightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Young Chung, Hallym University Kangnam Sacred Heart Hospital
- Investigators
- Bo Young Chung, M.D., PhD, Study chair, Department of Dermatology, Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722705
- Sponsor's protocol ID
- 2019-11-007
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention
- ClinicalTrials.gov ID
- NCT04722705
- Acronym / sponsor ID
- 2019-11-007
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 14 Nov 2021 (estimated)
- Study completion
- 14 Nov 2021 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| combined IPL/fractional Er:YAG laser treatment site | Experimental | Device: fractional Er:YAG laser, Device: Intense pulse lightAt 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. |
| fractional Er:YAG laser treatment alone site | Active comparator | Device: fractional Er:YAG laserAt 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. |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of postoperative scars on the abdomen
- scars were symmetrical shaped in a line of 3cm or more
Key exclusion criteria (6 listed)
- uncontrolled systemic or chronic disease
- hypersensitive to the ingredients
- a history of other laser treatments within the past 6 months
- pregnancy
- lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fractional Er:YAG laserAlso: Matrixell, Medro corp., Seoul, KoreaAt 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. | Device | combined IPL/fractional Er:YAG laser treatment site, fractional Er:YAG laser treatment alone site |
| Intense pulse lightAlso: IPL (Ellipse Flex, DDD, Hoersholm, Denmark)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. | Device | combined IPL/fractional Er:YAG laser treatment site |
Primary outcome
Patient Observer Scar Assessment Scale
Time frame: 4 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.
Patient Observer Scar Assessment Scale
Time frame: 8 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.
Patient Observer Scar Assessment Scale
Time frame: 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.
9 secondary outcomes
Total Vancouver Scar scale
Time frame: 4 weeks
Total Vancouver Scar scale
Time frame: 8 weeks
Total Vancouver Scar scale
Time frame: 20 weeks
Erythema index
Time frame: 4 weeks
Erythema index
Time frame: 8 weeks
Erythema index
Time frame: 20 weeks
Melanin index
Time frame: 4 weeks
Melanin index
Time frame: 8 weeks
Melanin index
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Young Chung, M.D., PhD study chair
Department of Dermatology, Kangnam Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fractional Er:YAG laser and Intense pulse light in people with Intense Pulsed Light and Erbium-yttrium Aluminum Garnet Laser, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Young Chung, M.D., PhD (+82-10-8940-4343, victoryby@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Observer Scar Assessment Scale (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.