Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT01591304
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2012-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study: Ulthera® System for the Treatment of Moderate to Severe Facial Acne
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-21', 'studyFirstSubmitDate': '2012-04-27', 'studyFirstSubmitQcDate': '2012-05-02', 'lastUpdatePostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in facial acne', 'timeFrame': '60 days post-treatment', 'description': 'Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in skin clarity', 'timeFrame': '180 days post-treatment', 'description': 'Measured using a digital imaging system comparing baseline and post-treatment images.'}, {'measure': 'Reduction of sebum production', 'timeFrame': '180 days post-treatment', 'description': 'Assessments using a sebumeter will be performed comparing pre-treatment and post-treatment assessments.'}, {'measure': 'Patient Satisfaction at 60 days', 'timeFrame': '60 day post-treatment', 'description': 'Patient satisfaction as determined by completion of a patient satisfaction questionnaire.'}, {'measure': 'Patient Satisfaction at 180 days', 'timeFrame': '180 Days post-treatment', 'description': 'Patient satisfaction as determined by completion of patient satisfaction questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ulthera® System', 'Ultherapy™ Treatment', 'Ulthera, Inc.'], 'conditions': ['Facial Acne']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.', 'detailedDescription': 'Study subjects will be assigned to one of two treatment groups. Both treatment groups will receive treatment in the center of the forehead/temples, medial cheeks, and chin regions using the 1.5mm and 1.0mm transducers.\n\n* For Group A, both the 1.5mm and 1.0mm transducers will be used at 0.25J energy setting and 0.20J energy setting, respectively.\n* For Group B, both the 1.5mm and 1.0mm transducers will be used at 0.18J energy setting and 0.15J energy setting, respectively.\n\nSubjects will receive 3 Ultherapy treatments administered 2 weeks apart. Subjects will be required to return for follow-up assessments at 14, 30, 60, 90 and 180 days following the third Ultherapy treatment. Pre- and post-treatment photos will be taken. In addition, pre- and post-treatment lesion counts and sebum measurements will be obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18 years and older.\n* Subject in good health.\n* Presence of clinically-evident facial acne of moderate to severe severity with at least 20 inflammatory lesions and 20-100 noninflammatory lesions.\n\nExclusion Criteria:\n\n* Presence of \\>2 nodular lesions in the areas to be treated.\n* Presence of any cysts in the areas to be treated.\n* Presence of an active systemic or local skin disease that may affect wound healing.\n* Use of alcohol-based topical solutions or "exfoliating" agents within 1 week prior to study participation.\n* History of frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.\n* History of keloid scar formation.\n* Significant scarring in areas to be treated.\n* Significant open facial wounds or lesions.\n* Presence of a metal stent or implant in the facial area to be treated.'}, 'identificationModule': {'nctId': 'NCT01591304', 'briefTitle': 'Feasibility Study: Ulthera® System for the Treatment of Moderate to Severe Facial Acne', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz North America, Inc.'}, 'officialTitle': 'Feasibility Study: Evaluation of the Safety and Effectiveness of the Ulthera® System for the Treatment of Moderate to Severe Facial Acne', 'orgStudyIdInfo': {'id': 'ULT-116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Ulthera System Treatment provided using 1.5mm and 1.0mm transducers at 0.25J and 0.20J energy settings, respectively.', 'interventionNames': ['Device: Ulthera System Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Ulthera System Treatment provided using 1.5mm and 1.0mm transducers, at 0.18J and 0.15J energy settings, respectively.', 'interventionNames': ['Device: Ulthera System Treatment']}], 'interventions': [{'name': 'Ulthera System Treatment', 'type': 'DEVICE', 'otherNames': ['Ulthera® System', 'Ultherapy™ Treatment', 'Ulthera, Inc.'], 'description': 'Focused ultrasound energy delivered below the surface of the skin.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91367', 'city': 'Woodland Hills', 'state': 'California', 'country': 'United States', 'facility': 'Multispecialty Aesthetic Clinical Research Organization', 'geoPoint': {'lat': 34.16834, 'lon': -118.60592}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology, Laser & Vein Specialists of the Carolinas', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Girish Munavalli, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology, Laser & Vein Specialists of the Carolinas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulthera, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}