Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-01-01 @ 1:22 PM
Study NCT ID:
NCT00857935
Status:
COMPLETED
Last Update Posted:
2009-03-09
First Post:
2009-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026023', 'term': 'Permethrin'}], 'ancestors': [{'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011722', 'term': 'Pyrethrins'}, {'id': 'D000081004', 'term': 'Cyclopentane Monoterpenes'}, {'id': 'D039821', 'term': 'Monoterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-06', 'studyFirstSubmitDate': '2009-03-05', 'studyFirstSubmitQcDate': '2009-03-06', 'lastUpdatePostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of NatrOVA Creme Rinse-1% versus NIX Creme rinse, based on the presence or absence of live lice 14 days after the final treatment.', 'timeFrame': '14 days after last treatment'}], 'secondaryOutcomes': [{'measure': 'Safety comparison between NatrOVA Creme Rinse-1% and NIX Creme Rinse, based on the occurrence of adverse events and any increase of scalp and/or ocular irritation, post-treatment.', 'timeFrame': '14 days after last treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pediculosis Capitis', 'Head Lice'], 'conditions': ['Pediculosis Capitis', 'Head Lice']}, 'descriptionModule': {'briefSummary': 'A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis', 'detailedDescription': 'A Phase 2b, randomized, single-site, investigator/evaluator blind, two-arm, parallel-group pilot study that tested the operational elements of an "Actual Use" study designed to evaluate the safety and efficacy of a 10-minute treatment and no-nit combing regimen of NatrOVA Creme Rinse 1% versus NIX Creme Rinse in subjects with at least a mild case of head lice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 6 months of age or older\n* Subject must have a head lice infestation present at baseline\n* Subject/caregiver must read English or Spanish at a 7th grade level\n* Subject must have an appropriately signed Informed Consent agreement\n* Other members of the household with a lice infestation must be willing to be enrolled in the study or treat their infestations with a standard treatment\n* Subject agreement to not use any other form of lice treatment during the course of the study\n* Subject agreement to not cut or chemically treat their hair in the period between baseline and final, post-treatment visits\n\nExclusion Criteria:\n\n* Individuals with a history of irritation or sensitivity to pediculicides or hair care products\n* Individuals with any visible skin/scalp condition at the treatment site that could interfere with the evaluation\n* Individuals previously treated with a pediculicide or any other head lice treatment product within 48 hours prior to enrollment\n* Individuals receiving systemic or topical drugs that may interfere with the study results\n* Individuals who have participated in a clinical trial within 30 days of enrollment\n* Individuals with family members who are infested with lice but are unwilling or unable to enroll in the study or to use the standard course of lice treatment\n* Females who are pregnant or nursing\n* Sexually-active females not using effective contraception'}, 'identificationModule': {'nctId': 'NCT00857935', 'briefTitle': 'A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse', 'organization': {'class': 'INDUSTRY', 'fullName': 'ParaPRO LLC'}, 'officialTitle': 'A Pilot Study to Test the Operational Elements of an Actual Use Study Designed to Compare the Safety and Efficacy of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months of Age or Older With Pediculosis Capitis', 'orgStudyIdInfo': {'id': 'SPN-203-07'}, 'secondaryIdInfos': [{'id': 'Concentrics 71007'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'NatrOVA Creme Rinse - 1%', 'interventionNames': ['Drug: NatrOVA Creme Rinse - 1%']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'NIX Creme Rinse', 'interventionNames': ['Drug: NIX Creme Rinse - 1% permethrin']}], 'interventions': [{'name': 'NatrOVA Creme Rinse - 1%', 'type': 'DRUG', 'description': 'NatrOVA Creme Rinse, one or two, 10-minute topical treatments (7 days apart)', 'armGroupLabels': ['1']}, {'name': 'NIX Creme Rinse - 1% permethrin', 'type': 'DRUG', 'description': 'NIX Creme Rinse: one or two, 10-minute topical treatments (7 days apart)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46240', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Concentrics Research', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Mark Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Concentrics Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ParaPRO LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark Moore, MD', 'oldOrganization': 'Concentrics Research'}}}}