Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-27 @ 4:08 PM
Study NCT ID:
NCT03043534
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2017-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pre-Shave Gel and Brush in Pseudofolliculitis Barbae
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563016', 'term': 'pseudofolliculitis barbae'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014099', 'term': 'Toothbrushing'}], 'ancestors': [{'id': 'D009910', 'term': 'Oral Hygiene'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amcmicha@wakehealth.edu', 'phone': '336-716-3775', 'title': 'Dr Amy McMichael', 'organization': 'WakeForest'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Gel and Brush', 'description': 'The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.\n\nshave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE\n\nBrush: All subjects randomized to brush will use the brush with each shave', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Global Severity Assessment- Mechanics of Shaving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gel and Brush', 'description': 'The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.\n\nshave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE\n\nBrush: All subjects randomized to brush will use the brush with each shave'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '12.9', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '8.5', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks', 'description': "A total of the Patient's Global Assessment of mechanics of shaving based on following scale:\n\nHow easy is it to… (please rank each phrase from 1 to 4; 1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult)\n\nA) get a smooth shave after shaving? \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nB) shave stubborn hairs? \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nC) shave against the grain with little irritation? \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nD) shave with the grain with little irritation? \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nE) glide comfortably over your skin with the razor blade?\n\nFor each subject, the total score could range from 5 -20, with lower numbers indicating better shave mechanics", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gel and Brush', 'description': 'The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.\n\nshave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE\n\nBrush: All subjects randomized to brush will use the brush with each shave'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.33', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '1.46', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Patient Global Severity Assessment measures itching/burning/stinging on the following scales:1 (no itching/no burning/no stinging at all) to 5 (very severe) the total score could range from 1-5 with the lower scores promoting a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gel and Brush', 'description': 'The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.\n\nshave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE\n\nBrush: All subjects randomized to brush will use the brush with each shave'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group'}], 'classes': [{'title': 'Baseline Shaving Experience', 'categories': [{'measurements': [{'value': '24.6', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '6.51', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Shaving Frustrations', 'categories': [{'measurements': [{'value': '13', 'spread': '5.38', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '2.59', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Achieving Results', 'categories': [{'measurements': [{'value': '12', 'spread': '4.88', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '4.55', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Skin Feel', 'categories': [{'measurements': [{'value': '13.2', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '4.59', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Skin-Confidence', 'categories': [{'measurements': [{'value': '16.3', 'spread': '6.49', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Social Interactions', 'categories': [{'measurements': [{'value': '19.4', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Shaving Experience', 'categories': [{'measurements': [{'value': '12.5', 'spread': '6.24', 'groupId': 'OG000'}, {'value': '20.5', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Shaving Frustrations', 'categories': [{'measurements': [{'value': '14.6', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Achieving Results', 'categories': [{'measurements': [{'value': '7.6', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Skin Feel', 'categories': [{'measurements': [{'value': '6.5', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Self-Confidence', 'categories': [{'measurements': [{'value': '10.8', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 Social Interactions', 'categories': [{'measurements': [{'value': '16.9', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '6.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks', 'description': "Quality of Life Survey will measure subjects' overall perception. For Shaving Experience, the total score could range from 6-42 with lower scores denoting better outcome measures.\n\nFor Shaving Frustration, the total score could range from 3-21 with higher scores denoting better outcome measures.\n\nFor Achieving Results, the total score could range from 3-21 with lower scores denoting better outcome measures.\n\nFor Skin Feel, the total score could range from 3-21 with lower scores denoting better outcome measures.\n\nFor Skin-Confidence, the total score could range from 4-28 with lower scores denoting better outcome measures.\n\nFor Social Interactions, the total score could range from 6-42 with lower scores denoting better outcome measures.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gel and Brush', 'description': 'The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.\n\nshave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE\n\nBrush: All subjects randomized to brush will use the brush with each shave'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '23.7', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '19.4', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Investigator Global Assessment (IGA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gel and Brush', 'description': 'The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.\n\nshave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE\n\nBrush: All subjects randomized to brush will use the brush with each shave'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.73', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '2.06', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '2.26', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Investigator Global Assessment (IGA) will measure disease severity using a scale 0 (Clear) - 5 (Very Severe) with the lower score grade denoting better outcome measures.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gel and Brush', 'description': 'The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.\n\nshave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE\n\nBrush: All subjects randomized to brush will use the brush with each shave'}, {'id': 'FG001', 'title': 'Control', 'description': 'Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gel and Brush', 'description': 'The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.\n\nshave gel: Non marketed pre-shave gel with the following INCI list of ingredients: WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE\n\nBrush: All subjects randomized to brush will use the brush with each shave'}, {'id': 'BG001', 'title': 'Control', 'description': 'Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2017-01-31', 'resultsFirstSubmitDate': '2017-04-19', 'studyFirstSubmitQcDate': '2017-02-03', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-19', 'studyFirstPostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Global Severity Assessment- Mechanics of Shaving', 'timeFrame': 'Baseline, 6 weeks', 'description': "A total of the Patient's Global Assessment of mechanics of shaving based on following scale:\n\nHow easy is it to… (please rank each phrase from 1 to 4; 1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult)\n\nA) get a smooth shave after shaving? \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nB) shave stubborn hairs? \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nC) shave against the grain with little irritation? \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nD) shave with the grain with little irritation? \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nE) glide comfortably over your skin with the razor blade?\n\nFor each subject, the total score could range from 5 -20, with lower numbers indicating better shave mechanics"}], 'secondaryOutcomes': [{'measure': 'Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Patient Global Severity Assessment measures itching/burning/stinging on the following scales:1 (no itching/no burning/no stinging at all) to 5 (very severe) the total score could range from 1-5 with the lower scores promoting a better outcome.'}, {'measure': 'Quality of Life Survey', 'timeFrame': 'Baseline, 6 weeks', 'description': "Quality of Life Survey will measure subjects' overall perception. For Shaving Experience, the total score could range from 6-42 with lower scores denoting better outcome measures.\n\nFor Shaving Frustration, the total score could range from 3-21 with higher scores denoting better outcome measures.\n\nFor Achieving Results, the total score could range from 3-21 with lower scores denoting better outcome measures.\n\nFor Skin Feel, the total score could range from 3-21 with lower scores denoting better outcome measures.\n\nFor Skin-Confidence, the total score could range from 4-28 with lower scores denoting better outcome measures.\n\nFor Social Interactions, the total score could range from 6-42 with lower scores denoting better outcome measures."}, {'measure': 'Lesions', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.'}, {'measure': 'Investigator Global Assessment (IGA)', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Investigator Global Assessment (IGA) will measure disease severity using a scale 0 (Clear) - 5 (Very Severe) with the lower score grade denoting better outcome measures.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pseudofolliculitis Barbae']}, 'descriptionModule': {'briefSummary': 'This will be a randomized investigator blinded study of 40 men age 20-60 (inclusive) with symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be divided into two groups: the Control group of 20 subjects and the Experimental group of 20 Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.\n\nAll subjects will use their normal razors and shave products during the six week study. The Experimental group of subjects will also be given the study product Pre-Shave Gel and Cleansing Brush.', 'detailedDescription': 'This will be a randomized investigator blinded study of up to 40 men age 20-60 (inclusive) with symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be divided into two groups: the Control group of 20 subjects and the Experimental group of 20 Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks.\n\nAll subjects will use their normal razors and shave products during the six week study. The Experimental group of subjects will also be given the study product Pre-Shave Gel and Cleansing Brush. The study gel and brush will be used prior to their normal shave routine.Quantitative lesion counts will be done by trained clinicians at each visit. Efficacy assessments include Investigator Global Assessment (IGA) scoring'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'les with psuedofolliculitis barbae', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males with at least a two year history of the symptoms of PFB.\n2. Must be age 20-60 years of age (inclusive).\n3. Must wet shave using just a prep and blade razor at least 3 or more times per week, and be willing to continue that regimen during the study.\n4. Must have Mild -to moderate PFB based on IGA rating scales. There are no lesion count inclusion requirements.\n\nExclusion Criteria:\n\n1. Use of systemic (oral antibiotics) within the last 4 weeks.\n2. Use of topical prescriptions (topical clindamycin, topical retinoids, topical metronidazole, topical sulfacetamide/sulfur, topical adapalene, benzoyl peroxide, salicylic acid, glycolic acid, retinol,chemical peels) or over-the-counter products the subject has used for PFB or Hair Growth within the last 2 weeks. Use of oral retinoids, laser therapy or electrolysis treatments or waxing in beard area in last 12 months.\n3. Individuals who do not wet shave with a bladed razor, or who use electric shavers.\n4. Subjects must not have used any type of cleansing or shave brush to the face for six weeks prior to Baseline.\n5. Individuals who have removed a beard within last two months.\n6. Individuals who have a history of alopecia areata of the face.\n7. Confounding dermatological conditions that would, in the opinion of the principal investigator, preclude participation in this study such as:\n\n * Immune deficiency disease (HIV positive, AIDS, sarcoidosis)\n * On immunosuppressive drugs (e.g. oral corticosteroids)\n * Autoimmune disease (lupus, scleroderma, diabetes mellitus, vitiligo)\n * Koebnerizing diseases (e.g. psoriasis, lichens planus, (HPV) human papilloma virus, facial verruca, molluscum contagiosum)\n * Tuberculosis, Hepatitis B\n * History of Keloids\n * History of Herpes simplex in treated area\n * Bacterial infection of face including abscesses and draining sinuses of facial area\n * Cystic Acne, other acne in bearded area which interferes with shaving as well as the ability to distinguish PFB lesions from acne'}, 'identificationModule': {'nctId': 'NCT03043534', 'briefTitle': 'Pre-Shave Gel and Brush in Pseudofolliculitis Barbae', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'The Impact of a Pre-Shave Gel and Brush in Males With Pseudofolliculitis Barbae', 'orgStudyIdInfo': {'id': 'IRB00034479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gel and Brush', 'description': 'The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.', 'interventionNames': ['Other: shave gel', 'Other: Brush']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group'}], 'interventions': [{'name': 'shave gel', 'type': 'OTHER', 'description': 'Non marketed pre-shave gel with the following INCI list of ingredients:\n\nWATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE', 'armGroupLabels': ['Gel and Brush']}, {'name': 'Brush', 'type': 'OTHER', 'otherNames': ['Oil of Olay cleansing brush'], 'description': 'All subjects randomized to brush will use the brush with each shave', 'armGroupLabels': ['Gel and Brush']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27104', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences Dept of Dermatology', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Amy McMIchael, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}