Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-27 @ 4:41 PM
Study NCT ID:
NCT02997904
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2016-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit on Pediatric and Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kpalma@piedmontpharma.com', 'phone': '336 544 0320', 'title': 'Dr. Kathy Palma', 'phoneExt': '202', 'organization': 'Piedmont Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Not without sponsor permission', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 Day', 'eventGroups': [{'id': 'EG000', 'title': 'Resultz Lice and Egg Removal Kit', 'description': 'Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour\n\nResultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Lice and Egg Removal Kit', 'description': '20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour\n\nResultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resultz Lice and Egg Elimination Kit', 'description': 'Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour\n\nResultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb'}, {'id': 'OG001', 'title': 'Sham Lice and Egg Elimination Kit', 'description': '20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour\n\nResultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb'}], 'classes': [{'categories': [{'measurements': [{'value': '71.3', 'spread': '61.2', 'groupId': 'OG000'}, {'value': '26.1', 'spread': '25.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0058', 'ciLowerLimit': '0.5829', 'ciUpperLimit': '1.4288', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2131', 'groupDescription': 'Ho: Total Number of lice and eggs removed with Resultz® ≤ Total number of lice and eggs removed with sham control Ha: Total Number of lice and eggs removed with Resultz® \\> Total Number of lice and eggs removed with sham control', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': 'A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.', 'unitOfMeasure': 'number of lice and eggs removed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent To Treat; including all subjects who were enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'Total Number of Lice Removed, Total Number of Eggs Removed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Number or Lice Removed by Resultz', 'description': 'Total number of lice removed after one hour of combing with Resultz; analyzed separately'}, {'id': 'OG001', 'title': 'Number of Lice Removed by Control', 'description': 'Total number of lice removed after one hour of combing by control; analyzed separately'}, {'id': 'OG002', 'title': 'Number of Eggs Removed by Resultz', 'description': 'Total number of eggs removed after one hour of combing, analyzed separately'}, {'id': 'OG003', 'title': 'Number of Eggs Removed by Control', 'description': 'Total number of eggs removed after one hour of combing by control, analyzed separately'}], 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'spread': '43.6', 'groupId': 'OG000'}, {'value': '12', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '31', 'spread': '22.3', 'groupId': 'OG002'}, {'value': '14.1', 'spread': '11.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2084', 'ciLowerLimit': '1.1157', 'ciUpperLimit': '1.3011', 'pValueComment': 'The P-Values were \\<0.0001 in both comparison groups; total number lice removed and total number of eggs removed', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04670', 'groupDescription': 'Comparison of total number of lice removed and total number of eggs removed were analyzed separately', 'statisticalMethod': 'GLIMMX', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7899', 'ciLowerLimit': '0.6993', 'ciUpperLimit': '0.8805', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04565', 'statisticalMethod': 'GLIMMX', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': 'Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately', 'unitOfMeasure': 'Number of Lice or Number of Eggs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent To Treat; including all subjects enrolled'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Resultz Lice and Egg Removal Kit', 'description': 'Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour\n\nResultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb'}, {'id': 'FG001', 'title': 'Sham Lice and Egg Removal Kit', 'description': '20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour\n\nResultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Resultz Lice and Egg Removal Kit', 'description': 'Resultz combing solution, head lice comb and instructions for use in a kit: kit used once and combed out for 1 hour\n\nResultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb'}, {'id': 'BG001', 'title': 'Sham Lice and Egg Removal Kit', 'description': '20% glycerin combing solution, comb and instructions for use in a kit: kit used once and combed out for 1 hour\n\nResultz Lice and Egg Removal Kit: Clear combing solution, nude colored comb'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '17.8', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '16.9', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-31', 'studyFirstSubmitDate': '2016-12-16', 'resultsFirstSubmitDate': '2017-06-28', 'studyFirstSubmitQcDate': '2016-12-19', 'lastUpdatePostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-31', 'studyFirstPostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing', 'timeFrame': '1 hour', 'description': 'A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.'}], 'secondaryOutcomes': [{'measure': 'Total Number of Lice Removed, Total Number of Eggs Removed', 'timeFrame': '1 hour', 'description': 'Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['lice comb', 'human head lice infestations', 'combing solution'], 'conditions': ['Pediculus Capitis']}, 'descriptionModule': {'briefSummary': 'A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically superior to a sham control with one hour of combing.', 'detailedDescription': 'Resultz Lice and Egg Elimination Kit will be efficacious in the removal of human head lice infestations in children and adult subjects under simulated real world conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have active head lice infestations (at least 1 live louse and eggs)\n* Good general health based on medical history\n* Each subject has to be consented\n\nExclusion Criteria:\n\n* Subjects with any condition that would compromise the study\n* History of irritation or sensitivity to pediculicides or hair care products\n* Subjects with cranial or facial implants\n* Subjects who have received radiation within the last 6 months\n* Subjects with history of heart disease\n* Subjects with history of epilepsy or seizure disorders\n* Subjects with neuro-stimulator or pacemaker\n* Subject with hair that staff cannot comb\n* Subject previously treated in study in last 30 days\n* Use of lice treatment in past 2 weeks\n* Subject unable to sense pain\n* Subject unable to communicate pain'}, 'identificationModule': {'nctId': 'NCT02997904', 'briefTitle': 'A Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit on Pediatric and Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Piedmont Pharmaceuticals, LLC'}, 'officialTitle': 'A Randomized Sham Controlled Double Blinded Single Site Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit for the Removal of Human Head Lice and Eggs on Pediatric and Adult Subjects', 'orgStudyIdInfo': {'id': 'PP-16-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resultz Lice and Egg Elimination Kit', 'description': 'Resultz combing solution, head lice comb and instructions for use in a kit: apply liquid then comb out for 1 hour', 'interventionNames': ['Device: Apply Liquid Then Comb Out']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Lice and Egg Elimination Kit', 'description': '20% glycerin combing solution, comb and instructions for use in a kit: apply liquid then comb out for 1 hour', 'interventionNames': ['Device: Apply Liquid Then Comb Out']}], 'interventions': [{'name': 'Apply Liquid Then Comb Out', 'type': 'DEVICE', 'otherNames': ['Resultz Application'], 'description': 'Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour', 'armGroupLabels': ['Placebo Lice and Egg Elimination Kit', 'Resultz Lice and Egg Elimination Kit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Lice Solution Resource Network Research', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}], 'overallOfficials': [{'name': 'Katie Shepherd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lice Solutions Resource Network Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Piedmont Pharmaceuticals, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Lice Solutions Resource Network (LSRN) Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}