Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT00467233
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2007-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Acid Peel and Laser for the Treatment of Melasma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008548', 'term': 'Melanosis'}], 'ancestors': [{'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053685', 'term': 'Laser Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-30', 'studyFirstSubmitDate': '2007-04-26', 'studyFirstSubmitQcDate': '2007-04-26', 'lastUpdatePostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MASI', 'timeFrame': '20 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '20 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Melasma']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate laser treatment and acid peel for the treatment of melasma.', 'detailedDescription': 'The purpose of this study is to evaluate the safety and efficacy of laser treatment and acid peel for the treatment of melasma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of melasma lesion measuring at least 4 square centimeters.\n* Age 18-75 years.\n* Good health.\n* Willingness and ability to understand and provide informed consent for participation in the study.\n* Ability to communicate with the investigator.\n* Must be willing to forgo other treatment options for melasma during the course of the study.\n\nExclusion Criteria:\n\n* Inability to understand the protocol or to give informed consent.\n* Mental illness.\n* Under 18 years of age and over 75 years of age.\n* Laser treatment in the last 6 months before enrollment.\n* Isotretinoin within the past year.\n* Lidocaine allergy.\n* History of herpes simplex viral infection.\n* Concurrent active disease to facial area (i.e acne).\n* Bleeding disorder.\n* History of abnormal wound healing.\n* History of abnormal scarring.'}, 'identificationModule': {'nctId': 'NCT00467233', 'briefTitle': 'Study of Acid Peel and Laser for the Treatment of Melasma', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'A Randomized, Rater-blinded, Split-face Comparison of the Efficacy of 30 % Salicylic Acid Peel vs. Q-switched Nd:Yag Laser for the Treatment of Melasma.', 'orgStudyIdInfo': {'id': 'STU679'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Laser Treatment', 'interventionNames': ['Procedure: Laser Treatment']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Acid peel', 'interventionNames': ['Procedure: Acid Peel']}], 'interventions': [{'name': 'Laser Treatment', 'type': 'PROCEDURE', 'description': 'Laser treatment to half of the face at each study visit', 'armGroupLabels': ['1']}, {'name': 'Acid Peel', 'type': 'PROCEDURE', 'description': 'Acid peel to half of the face at each study visit', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine, Department of Dermatology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Murad Alam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation', 'investigatorFullName': 'Murad Alam', 'investigatorAffiliation': 'Northwestern University'}}}}