Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-06 @ 12:33 AM
Study NCT ID:
NCT00110734
Status:
COMPLETED
Last Update Posted:
2005-09-23
First Post:
2005-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Laser-Assisted Tattoo Removal in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2005-09'}, 'lastUpdateSubmitDate': '2005-09-21', 'studyFirstSubmitDate': '2005-05-12', 'studyFirstSubmitQcDate': '2005-05-12', 'lastUpdatePostDateStruct': {'date': '2005-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-05-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of S-Caine Peel when applied for 60 minutes for induction of local dermal anesthesia prior to laser-assisted tattoo removal in adults'}], 'secondaryOutcomes': [{'measure': 'To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel'}]}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'There is pain associated with laser-assisted tattoo removal. For this reason, some form of anesthesia is commonly used to eliminate or minimize the pain. This anesthesia is usually a topical local anesthetic cream or ointment spread over the skin. The purpose of this study is to further estimate the effectiveness of S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) for treating pain during laser-assisted tattoo removal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is 18 years of age or older\n* Patient elects to undergo laser-assisted tattoo removal\n\nExclusion Criteria:\n\n* Patient is pregnant or breastfeeding\n* Patient has participated in a clinical trial of an unapproved drug within the previous 30 days\n* Patient has participated in any previous clinical trial involving S-Caine Peel'}, 'identificationModule': {'nctId': 'NCT00110734', 'briefTitle': 'S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Laser-Assisted Tattoo Removal in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'ZARS Pharma Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo Controlled, Paired Study Evaluating S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) for Induction of Local Dermal Anesthesia for Laser-Assisted Tattoo Removal in Adults', 'orgStudyIdInfo': {'id': 'SCP-43-05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Laser and Skin Surgery Center of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZARS Pharma Inc.', 'class': 'INDUSTRY'}}}}