Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 9:39 PM
Study NCT ID:
NCT01504061
Status:
COMPLETED
Last Update Posted:
2013-10-24
First Post:
2011-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mederma to Reduce Appearance of Post Surgical Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-23', 'studyFirstSubmitDate': '2011-12-06', 'studyFirstSubmitQcDate': '2012-01-02', 'lastUpdatePostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator assessment of post-surgical scar appearance (indices are erythema, softness, texture, and overall appearance). This assessment is accompanied by photography and dermaspectrophotometry.', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['surgical', 'scars', 'Mederma'], 'conditions': ['Scars']}, 'descriptionModule': {'briefSummary': 'This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of Mederma N\\&I to Mederma Ultra Gel on the appearance of post-surgical scars.', 'detailedDescription': 'This is a 10-week research study designed to compare the effect of two gels on the appearance of post surgical scarring of the chest and/or back. The subject will be asked to identify two symmetrical skin growths that they would like to have removed: one on the left chest and/or back and one on the right chest and/or back. Additionally, the subject will identify a third skin growth that they would like removed which is a reasonable distance from the two symmetrical skin growths and will be located either on the back or the chest.\n\nInclusion Criteria:\n\n* Healthy male and non pregnant female subjects ≥18 years of age\n* have seborrheic keratoses on the right and left chest and/or back\n\nExclusion Criteria:\n\n-Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be 18-70 years of age, of any race or sex.\n* Subjects must be Fitzpatrick skin type I-VI.\n* Subjects must have two symmetrical upper chest and/or back seborrheic keratoses and in the opinion of the investigator are good candidates for the study.\n\nExclusion Criteria:\n\n* Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.\n* Subjects with known history of keloids or hypertrophic scars.'}, 'identificationModule': {'nctId': 'NCT01504061', 'briefTitle': 'Mederma to Reduce Appearance of Post Surgical Scars', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'The Comparison of Mederma® N&I to Mederma® Ultra Gel to Reduce the Appearance of Post Surgical Scars', 'orgStudyIdInfo': {'id': 'MUS90025-4007-0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mederma Ultra Gel', 'interventionNames': ['Other: Mederma Ultra Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mederma N&I', 'interventionNames': ['Other: Mederma N&I']}], 'interventions': [{'name': 'Mederma N&I', 'type': 'OTHER', 'description': 'Topical gel applied three times a day for eight weeks.', 'armGroupLabels': ['Mederma N&I']}, {'name': 'Mederma Ultra Gel', 'type': 'OTHER', 'description': 'Topical gel applied once daily for eight weeks.', 'armGroupLabels': ['Mederma Ultra Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Girish Munavalli, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology, Laser, and Vein Specialists of Carolinas, PLLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz North America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}