Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-08 @ 5:27 PM
Study NCT ID:
NCT04722705
Status:
UNKNOWN
Last Update Posted:
2021-01-26
First Post:
2021-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-11-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-22', 'studyFirstSubmitDate': '2021-01-20', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Observer Scar Assessment Scale', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': 'Patient Observer Scar Assessment Scale', 'timeFrame': '8 weeks', 'description': '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.'}, {'measure': 'Patient Observer Scar Assessment Scale', 'timeFrame': '20 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Total Vancouver Scar scale', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': 'Total Vancouver Scar scale', 'timeFrame': '8 weeks', 'description': '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.'}, {'measure': 'Total Vancouver Scar scale', 'timeFrame': '20 weeks', 'description': '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.'}, {'measure': 'Erythema index', 'timeFrame': '4 weeks', 'description': '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).\n\nThis measurement was performed to determine erythema.'}, {'measure': 'Erythema index', 'timeFrame': '8 weeks', 'description': '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).\n\nThis measurement was performed to determine erythema.'}, {'measure': 'Erythema index', 'timeFrame': '20 weeks', 'description': '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).\n\nThis measurement was performed to determine erythema.'}, {'measure': 'Melanin index', 'timeFrame': '4 weeks', 'description': '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).\n\nThis measurement was performed to determine pigmentation.'}, {'measure': 'Melanin index', 'timeFrame': '8 weeks', 'description': '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).\n\nThis measurement was performed to determine pigmentation.'}, {'measure': 'Melanin index', 'timeFrame': '20 weeks', 'description': '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).\n\nThis measurement was performed to determine pigmentation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intense Pulsed Light', 'Erbium-yttrium Aluminum Garnet Laser', 'Scar Prevention']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of postoperative scars on the abdomen\n* scars were symmetrical shaped in a line of 3cm or more\n\nExclusion Criteria:\n\n* uncontrolled systemic or chronic disease\n* hypersensitive to the ingredients\n* a history of other laser treatments within the past 6 months\n* pregnancy\n* lactation\n* Recent sun exposure'}, 'identificationModule': {'nctId': 'NCT04722705', 'briefTitle': 'Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Kangnam Sacred Heart Hospital'}, 'officialTitle': 'Efficacy of Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention', 'orgStudyIdInfo': {'id': '2019-11-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'combined IPL/fractional Er:YAG laser treatment site', 'description': 'At baseline, three lesions were randomized to IPL / fractional Er:YAG laser combination therapy site.\n\nTopical 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.\n\nThe 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.', 'interventionNames': ['Device: fractional Er:YAG laser', 'Device: Intense pulse light']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fractional Er:YAG laser treatment alone site', 'description': 'At baseline, three lesions were randomized to fractional Er:YAG laser combination therapy site.\n\nTopical 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.\n\nThe 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.', 'interventionNames': ['Device: fractional Er:YAG laser']}, {'type': 'NO_INTERVENTION', 'label': 'untreated control site', 'description': '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': [{'name': 'fractional Er:YAG laser', 'type': 'DEVICE', 'otherNames': ['Matrixell, Medro corp., Seoul, Korea'], 'description': 'At baseline, three lesions were randomized. Topical anesthetic cream was applied to the scar 30 minutes before laser treatment.\n\nThe 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.', 'armGroupLabels': ['combined IPL/fractional Er:YAG laser treatment site', 'fractional Er:YAG laser treatment alone site']}, {'name': 'Intense pulse light', 'type': 'DEVICE', 'otherNames': ['IPL (Ellipse Flex, DDD, Hoersholm, Denmark)'], 'description': 'At baseline, three lesions were randomized. Topical anesthetic cream was applied to the scar 30 minutes before laser treatment.\n\nThe 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.', 'armGroupLabels': ['combined IPL/fractional Er:YAG laser treatment site']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07441', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin Cheol Kim, MD', 'role': 'CONTACT', 'email': 'aiekfne@naver.com', 'phone': '+82-10-4350-9110'}], 'facility': 'Kangnam Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Bo Young Chung, M.D., PhD', 'role': 'CONTACT', 'email': 'victoryby@naver.com', 'phone': '+82-10-8940-4343'}], 'overallOfficials': [{'name': 'Bo Young Chung, M.D., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Dermatology, Kangnam Sacred Heart Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Kangnam Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Professor', 'investigatorFullName': 'Bo Young Chung', 'investigatorAffiliation': 'Hallym University Kangnam Sacred Heart Hospital'}}}}