Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-22 @ 7:05 AM
Study NCT ID:
NCT00641420
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2008-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-11-15', 'releaseDate': '2023-02-02'}, {'resetDate': '2024-09-05', 'releaseDate': '2024-04-16'}], 'estimatedResultsFirstSubmitDate': '2023-02-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017495', 'term': 'Hyperpigmentation'}], 'ancestors': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2008-03-17', 'studyFirstSubmitQcDate': '2008-03-21', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in acne scarring.', 'timeFrame': '6 months', 'description': 'Blinded evaluators will score improvement of acne via photographs using a quartile grading scale (0 = no improvement, 1 = minor improvement \\[1-25%\\], 2 =moderate improvement \\[26-50%\\], 3 =marked improvement \\[51-75%\\], 4 = very significant improvement \\[76-100%\\]).'}], 'secondaryOutcomes': [{'measure': 'Dyspigmentation', 'timeFrame': '6 months', 'description': 'dyspigmentation will be assessed separately from acne scarring via photographs with blinded evaluators on a scale of 1- 3. 1 (minimal amount of hyperpigmentation), 2 (moderate hyperpigmentation) and 3 (severe amount of hyperpigmentation) depending on the degree of hyperpigmentation compared with their baseline photo.'}, {'measure': 'Pain with treatment', 'timeFrame': '5 months', 'description': 'subjects will report any pain with treatment on a 0-10 scale, with zero indicating no pain and 10 indicating the worst pain'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acne scarring', 'Post inflammatory hyperpigmentation'], 'conditions': ['Acne Scarring']}, 'descriptionModule': {'briefSummary': 'Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair skinned individuals. This study aims to test the efficacy and safety in darker skin types. Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five treatments at 17% one month apart. Improvement is judged by a dermatologist as 0-25%, 25-50%, 50-75% or 75-100%. Side effects such as pigmentary abnormalities and pain are also evaluated.', 'detailedDescription': 'Background: Ablative resurfacing lasers are effective for treatment of acne scars, but they have a high risk of complications. Fractional lasers have less severe side effects but more moderate efficacy than ablative devices. Studies were performed in individuals with Fitzpatrick skin type I to VI.\n\nObjective: To determine the efficacy and safety of an erbium 1,550-nm fractional laser in the treatment of facial acne scars in Fitzpatrick skin types IV to VI.\n\nMethods: We conducted a prospective, single-blind, randomized trial in patients with acne scars (n=15), skin type IV to VI, with a 1,550-nm erbium fractionated laser. Patients were divided into two groups; one was treated with 10 mJ and the other with 40 mJ. Five monthly laser sessions were performed. A patient questionnaire was distributed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female voluntary patients between the ages of 18 and 59 with Fitzpatrick skin type IV-VI as verified by one of the investigators\n* Patients with clinical diagnosis of ice pick, rolling, or boxcar type ane scarring\n* Patients able to follow instructions\n* If patient has a history of cold sores (herpes labialis) they must be willing to take prophylactic valtrex\n* Written informed consent from the patients (Appendix II)\n\nExclusion Criteria:\n\n* Children (less than 18 years old)\n* Pregnant or lactating women\n* Personal history of keloids or hypertrophic scarring\n* Active acne requiring topical or oral therapy\n* Accutane or other oral retinoid in past year\n* Patients with a known allergy to lidocaine\n* Allergy to valacyclovir in a patient that needs prophylaxis\n* Patients with an unstable or non controlled underlying medical problem\n* Patients who are not able to follow instructions\n* Patients who have participated in a study within the 3 months prior to study entry\n* Patients who refuse to give written informed consent\n* Patients with a history of a pigmentary abnormality'}, 'identificationModule': {'nctId': 'NCT00641420', 'briefTitle': 'Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin', 'orgStudyIdInfo': {'id': 'HenryFord4447'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fractional Laser 10mJ', 'description': 'Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ.', 'interventionNames': ['Procedure: Fractionated Laser Resurfacing']}, {'type': 'EXPERIMENTAL', 'label': 'Fractional Laser 40mJ', 'description': 'Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ.', 'interventionNames': ['Procedure: Fractionated Laser Resurfacing']}], 'interventions': [{'name': 'Fractionated Laser Resurfacing', 'type': 'PROCEDURE', 'otherNames': ['Fractionated Laser: FRAXEL'], 'armGroupLabels': ['Fractional Laser 10mJ', 'Fractional Laser 40mJ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'David M Ozog, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Staff', 'investigatorFullName': 'David M. Ozog', 'investigatorAffiliation': 'Henry Ford Health System'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-02-02', 'type': 'RELEASE'}, {'date': '2023-11-15', 'type': 'RESET'}, {'date': '2024-04-16', 'type': 'RELEASE'}, {'date': '2024-09-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'David M. Ozog, Senior Staff, Henry Ford Health System'}}}}