Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 3:27 AM
Study NCT ID:
NCT04312750
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2020-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adhesion of Lidocaine Topical System 1.8%
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-03-16', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Cumulative Adhesion Score', 'timeFrame': '0, 3, 6, 9, 12 hours post-dose', 'description': 'Adhesion of the topical system to the skin is assessed by FDA 0-4 scoring system. The scoring for adhesion of topical systems is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to \\< 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to \\< 75% Adhered (less than half of the patch lifting off the skin), \\> 0% to \\< 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). The mean cumulative adhesion score is calculated as the sum of scores at each assessment time point divided by the total number of observations.'}], 'secondaryOutcomes': [{'measure': 'Dermal Response Score', 'timeFrame': '12.5 and 14 hours post-dose', 'description': 'Product tolerability is assessed by Dermal Response Score. The application site is evaluated 30 minutes and 2 hours after product removal (12.5 and 14 hours post-dose, respectively). Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test (i.e., application) site.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '33654425', 'type': 'DERIVED', 'citation': 'Gudin J, Webster LR, Greuber E, Vought K, Patel K, Kuritzky L. Open-Label Adhesion Performance Studies of a New Lidocaine Topical System 1.8% versus Lidocaine Patches 5% and Lidocaine Medicated Plaster 5% in Healthy Subjects. J Pain Res. 2021 Feb 23;14:513-526. doi: 10.2147/JPR.S287153. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the adhesion performance of ZTlido (lidocaine topical system) 1.8% in normal, healthy volunteers.', 'detailedDescription': 'In this open-label, single-treatment, single-period, single-application adhesion performance study, 54 healthy, adult male and female subjects are treated with one lidocaine topical system to their back for 12 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed after the topical system is removed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Must be healthy based on by medical history, laboratory work, and physical exam\n* Be at least 18 years of age\n* If childbearing potential, use of acceptable form of birth control\n* In the case of females of childbearing potential, have a negative serum pregnancy test\n\nKey Exclusion Criteria:\n\n* Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation\n* Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness\n* Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)\n* History of addiction, abuse, and misuse of any drug'}, 'identificationModule': {'nctId': 'NCT04312750', 'briefTitle': 'Adhesion of Lidocaine Topical System 1.8%', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scilex Pharmaceuticals, Inc.'}, 'officialTitle': 'An Open Label, Single-treatment, Single-period, Single-application, Adhesion Performance Study of Lidocaine Patch 36 mg/Patch (1.8%) in Healthy, Adult, Human Subjects.', 'orgStudyIdInfo': {'id': 'SCI-LIDO-ADH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine Patch', 'description': "All subjects received one lidocaine topical system, which was applied to a predetermined fixed area on subject's left side of the back or right side of the back (lower/mid back) according to randomization schedule and worn for 12 hours.", 'interventionNames': ['Drug: Lidocaine topical system 1.8%']}], 'interventions': [{'name': 'Lidocaine topical system 1.8%', 'type': 'DRUG', 'otherNames': ['Lidocaine patch 1.8%', 'ZTlido'], 'armGroupLabels': ['Lidocaine Patch']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anthony Godfrey, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AXIS Clinicals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scilex Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}