Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT03569956
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2018-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shaving Satisfaction in Males With Skin Irritation From Shaving
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563016', 'term': 'pseudofolliculitis barbae'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be divided into two groups: the Razor group of 20 subjects, and the Regimen group of 20 subjects. In the Razor group, subjects will use the 556 Razor with their regular shaving products, and shave at least 5 or more times per week. In the Regimen group, subjects will use the 556 Razor, Pre-Shave Gel, Cleansing brush and Shaving Gel, and shave at least 5 or more times per week. All subjects will be given the 556 Razors during the 12-week study. The Regimen group will also be given the Pre-Shave Gel, Cleansing Brush, and Shaving Gel.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2018-06-15', 'studyFirstSubmitQcDate': '2018-06-15', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Patient's Global Severity Assessment (PGSA)- satisfaction of shaving experience", 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': "Change in the satisfaction of Shaving experience by subjects completing the patients's global severity assessment during the 12 week study. The score range is 0-30. The lower the scores, the better the outcome."}, {'measure': "Change in Patient's Global Severity Assessments- skin irritation", 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': "Change in skin irritation will be evaluated by subjects by completing the patients's global severity assessment during the 12 week study. The score range is 0-30. The lower the scores, the better the outcome."}], 'primaryOutcomes': [{'measure': 'Change in Shaving Satisfaction and Appearance score', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Shaving Satisfaction and Appearance will be captured by the subject during 12 week time frame to document changes in severity and appearance and assessed by the Patient Global Severity Assessment. The score range is 0-30. The lower the scores; the better the outcome.'}, {'measure': 'Change in Investigator Global Severity Assessment (IGA) score', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Disease severity will be assessed Investigator Global Severity Assessment (IGA). Appearance will be captured by the PI by using a scale 0 (clear) to 5 (very severe) during the 12 week time frame to document changes in severity and appearance. The score range is 0-5. The lower the scores, the better the outcome.'}], 'secondaryOutcomes': [{'measure': 'Disease severity assessed by lesion counts', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12', 'description': 'Disease severity will be assessed by lesion counts of any follicular papules in the beard area (not including acne) pustules, excoriations, hyperpigmentation, and ingrown hairs. Higher scores are indicative of worse outcome because more lesions mean more involvement of the razor bumps and associated inflammation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Razor bumps', 'Skin Irritation', 'Shaving'], 'conditions': ['Pseudofolliculitis Barbae']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate the improvement in overall shave satisfaction, the appearance of skin irritation from shaving, and the razor related inflammation of the hair follicles when using a new razor technology in a regular shaving regimen as well as a new razor technology in a shaving regimen that includes a pre-shave gel, cleansing brush and shaving gel.', 'detailedDescription': 'A secondary objective is to show improvement in the satisfaction of the shaving experience, symptoms such as bumps and irritation, and quality of life (QOL), when adding the 556 Razor, or the 556 Razor with a regimen of pre-shave gel, cleansing brush, and shave gel to the shaving regimen of males with shaving skin irritation. Shaving irritation severity will be correlated to shave satisfaction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males with at least a two year history of the symptoms of skin irritation from shaving.\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 shave at least 5 times per week during the study\n4. Must have Mild to moderate symptoms of skin irritation from shaving based on IGA rating scales. There must be the presence of some razor bumps but there are no lesion count inclusion requirements.\n\nExclusion Criteria:\n\n1. Changes in the use of systemic (oral antibiotics) within the last 4 weeks. Stable use of oral antibiotics for any condition are allowed\n2. Changes in the use of topical prescriptions\n3. Individuals who do not wet shave with a bladed razor, or who use electric shavers.\n4. Individuals who have removed a beard within last two months.'}, 'identificationModule': {'nctId': 'NCT03569956', 'briefTitle': 'Shaving Satisfaction in Males With Skin Irritation From Shaving', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'The Impact of the 556 Razor Technology and of a Regimen of the 556 Razor Technology With Pre-Shave Gel and Brush on Shaving Satisfaction in Males With Skin Irritation From Shaving', 'orgStudyIdInfo': {'id': 'IRB00051291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Razor Group', 'description': 'Subject will use the 556 razor with regular shaving products, and shave at least 5 or more times per week', 'interventionNames': ['Other: 556 Razor']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen', 'description': 'Subject will use the 556 razor with the Pre-shave Gel, Cleaning Brush, and Shaving Gel and shave at least 5 or more times per week.', 'interventionNames': ['Other: 556 Razor']}], 'interventions': [{'name': '556 Razor', 'type': 'OTHER', 'description': 'In the Razor group, subjects will use the 556 Razor with their regular shaving products, and shave at least 5 or more times per week. In the Regimen group, subjects will use the 556 Razor, Pre-Shave Gel, Cleansing brush and Shaving Gel, and shave at least 5 or more times per week. All subjects will be given the 556 Razors during the 12-week study. The Regimen group will also be given the Pre-Shave Gel, Cleansing Brush, and Shaving Gel.', 'armGroupLabels': ['Razor Group', 'Regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Amy J McMichael, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Procter and Gamble', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}