Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT02801903
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2016-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Topical SB204 in Adolescents 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709171', 'term': 'berdazimer sodium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2016-06-09', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration', 'timeFrame': 'Day 21', 'description': 'Maximum plasma concentration of plasma hMAP3 on Day 21'}, {'measure': 'AUC - area under the plasma concentration time curve for hMAP3', 'timeFrame': 'Day 21', 'description': 'AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma hMAP3 on Day 21'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics as measured by maximum concentration of nitrate', 'timeFrame': 'Day 21', 'description': 'Cmax: maximum plasma concentration of plasma nitrate on Day 21'}, {'measure': 'Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3', 'timeFrame': 'Day 21', 'description': 'AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma nitrate on Day 21'}, {'measure': 'Safety profile (Reported adverse events)', 'timeFrame': 'Day 21/End of Treatment', 'description': 'Reported adverse events'}, {'measure': 'Tolerability (Scores on tolerability assessment)', 'timeFrame': 'Day 21/End of treatment', 'description': 'Scores on tolerability assessment during treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris', 'detailedDescription': 'This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day 21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point IGA scale\n* At least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders\n* Age 9-16 years, 11 months inclusive\n* Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse co-oximeter\n\nExclusion Criteria:\n\n* Subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis;\n* Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.\n* Subjects who reside in a dwelling that relies on well water for a primary drinking source\n* Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application\n* Transgender subjects receiving hormone supplement (male to female or female to male)\n* Subjects with a previous history of methemoglobinemia or taking medications known to be associated with methemoglobinemia\n* Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens\n* Females who are pregnant, planning a pregnancy or breastfeeding\n* Subjects previously treated with NVN1000 Gel / SB204'}, 'identificationModule': {'nctId': 'NCT02801903', 'briefTitle': 'Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novan, Inc.'}, 'officialTitle': 'A Phase 1, Single-center, Open-label Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents With Moderate to Severe Acne Vulgaris', 'orgStudyIdInfo': {'id': 'NI-AC103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SB204 4%', 'description': 'Topically Once Daily (AM)', 'interventionNames': ['Drug: SB204 4%']}], 'interventions': [{'name': 'SB204 4%', 'type': 'DRUG', 'otherNames': ['NVN1000'], 'description': 'Topically Once Daily (AM)', 'armGroupLabels': ['SB204 4%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'WCCT #1', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'M. Joyce Rico, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novan, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novan, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'WCCT Global', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}