Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-27 @ 2:28 AM
Study NCT ID:
NCT02218034
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2014-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-28', 'studyFirstSubmitDate': '2014-08-14', 'studyFirstSubmitQcDate': '2014-08-14', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Level (Cmax) of AGN-190168', 'timeFrame': 'Day 29'}, {'measure': 'Maximum Plasma Level (Cmax) of AGN-190168 Metabolite', 'timeFrame': 'Day 29'}, {'measure': 'Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale', 'timeFrame': 'Day 29'}, {'measure': 'Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale', 'timeFrame': 'Day 29'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of acne vulgaris on the face\n* No tobacco use for the past 30 days, and willing to refrain from nicotine use during the study\n* Willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet light (eg, sunlight, tanning beds) and extremes in weather, such as wind or cold, throughout the study\n* If male, willing to maintain routine shaving regimen for the duration of the study and avoid shaving 12 hours prior to specified visits\n* Females of childbearing potential must use a reliable method of contraception\n\nExclusion Criteria:\n\n* Use of phototherapy devices (eg, ClearLight™) and adhesive cleansing strips (eg, Ponds® and Biore®), as well as cosmetic procedures (eg, facials, peeling, and comedone extraction) in the area to be treated in the past 1 week\n* Use of topical anti-inflammatory drugs, salicylic acid (eg, Clearasil® and Clean \\& Clear®), corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products \\[eg, benzamycin\\]), retinoids, and other topical acne treatments (eg, photodynamic therapy, laser therapy, and medicated soaps) in the area to be treated in the past 2 weeks\n* Ability to abstain from caffeine-containing products on the dates instructed'}, 'identificationModule': {'nctId': 'NCT02218034', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '190168-069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AGN-190168 Formulation 1', 'description': 'AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.', 'interventionNames': ['Drug: AGN-190168 Formulation 1']}, {'type': 'EXPERIMENTAL', 'label': 'AGN-190168 Formulation 2', 'description': 'AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.', 'interventionNames': ['Drug: AGN-190168 Formulation 2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAZORAC® Gel 0.1%', 'description': 'TAZORAC® Gel 0.1% (tazarotene gel 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.', 'interventionNames': ['Drug: tazarotene gel 0.1%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAZORAC® Cream 0.1%', 'description': 'TAZORAC® Cream 0.1% (tazarotene cream 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.', 'interventionNames': ['Drug: tazarotene cream 0.1%']}], 'interventions': [{'name': 'AGN-190168 Formulation 1', 'type': 'DRUG', 'description': 'AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.', 'armGroupLabels': ['AGN-190168 Formulation 1']}, {'name': 'AGN-190168 Formulation 2', 'type': 'DRUG', 'description': 'AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.', 'armGroupLabels': ['AGN-190168 Formulation 2']}, {'name': 'tazarotene gel 0.1%', 'type': 'DRUG', 'otherNames': ['TAZORAC® Gel 0.1%'], 'description': 'Tazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.', 'armGroupLabels': ['TAZORAC® Gel 0.1%']}, {'name': 'tazarotene cream 0.1%', 'type': 'DRUG', 'otherNames': ['TAZORAC® Cream 0.1%'], 'description': 'Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.', 'armGroupLabels': ['TAZORAC® Cream 0.1%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}