Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-29 @ 3:41 PM
Study NCT ID:
NCT00386204
Status:
COMPLETED
Last Update Posted:
2008-06-04
First Post:
2006-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Side Effects of Q-Switched Ruby Laser for the Treatment of Lentigines in Light and Dark Skin Types
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2006-09'}, 'lastUpdateSubmitDate': '2008-06-02', 'studyFirstSubmitDate': '2006-10-10', 'studyFirstSubmitQcDate': '2006-10-10', 'lastUpdatePostDateStruct': {'date': '2008-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Clearance'}, {'measure': 'Side Effects'}]}, 'conditionsModule': {'keywords': ['Q-switched Ruby laser'], 'conditions': ['Solar Lentigines']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is a comparison of efficacy and side effects of Q-switched Ruby laser treatment for solar lentigines in two different skin types II and IV.', 'detailedDescription': 'It has been widely accepted that dark colored individuals are prone to develop laser induced side effects especially post inflammatory hyperpigmentation(PIH) and it could be a limiting issue in selecting dark colored individuals.\n\nWe designed this study to evaluate the difference of efficacy and side effects in light and dark skinned individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Solar Lentigines\n* Fitzpatrick skin type II and IV\n\nExclusion Criteria:\n\n* Pregnancy\n* Age above 80\n* Photosensitivity\n* Concern for malignancy\n* Active Infection'}, 'identificationModule': {'nctId': 'NCT00386204', 'briefTitle': 'Side Effects of Q-Switched Ruby Laser for the Treatment of Lentigines in Light and Dark Skin Types', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Efficacy and Side Effects of Q-Switched Ruby Laser Treatment of Solar Lentigines in Two Different Fitzpatrick Skin Types II and IV', 'orgStudyIdInfo': {'id': 'src-pts-11073'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Q-switched Ruby Laser', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19899', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Skin Research Center, Shohada-e Tajrish Hospital, Shaheed Beheshti Medical University', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Parviz Toossi, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}}}}