Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT03779295
Status:
WITHDRAWN
Last Update Posted:
2022-03-03
First Post:
2018-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Therapy for Perioral Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019557', 'term': 'Dermatitis, Perioral'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005148', 'term': 'Facial Dermatoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002981', 'term': 'Clindamycin'}], 'ancestors': [{'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The investigators will not remind the participant or other investigators which side of the face received laser therapy, however the investigators cannot completely "blind" either the participant or other investigators as they will be awake or performing the therapy, respectively.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a split face prospective trial. The face will be treated in halves. The halves will be randomized to receive topical clindamycin or PDL therapy and clindamycin. Both halves of the face will be treated with topical clindamycin. Per randomization, half of the face will be treated with pulse dye laser therapy at 595 nm, using 6.5 J/cm2, 10 mm spot size and a 6 millisecond pulse width.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No subjects enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2018-12-12', 'studyFirstSubmitQcDate': '2018-12-14', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in number of lesions on side of the subject's face receiving laser therapy", 'timeFrame': 'initial study visit', 'description': 'counting number of lesions on each side of the face'}, {'measure': "Change in number of lesions on side of the subject's face receiving laser therapy", 'timeFrame': '4 weeks', 'description': 'counting number of lesions on each side of the face'}, {'measure': "Change in number of lesions on side of the subject's face receiving laser therapy", 'timeFrame': '8 weeks', 'description': 'counting number of lesions on each side of the face'}, {'measure': "Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)", 'timeFrame': 'initial study visit', 'description': 'counting number of lesions on each side of the face'}, {'measure': "Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)", 'timeFrame': '4 weeks', 'description': 'counting number of lesions on each side of the face'}, {'measure': "Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)", 'timeFrame': '8 weeks', 'description': 'counting number of lesions on each side of the face'}], 'secondaryOutcomes': [{'measure': 'Patient opinion of side that improved more', 'timeFrame': '4 weeks', 'description': 'Patients will grade satisfaction of treatment by answering "Which side of their face improved more from treatment?" with the option of responding "the right side/the left side/they are the same."'}, {'measure': 'Patient opinion of side that improved more', 'timeFrame': '8 weeks', 'description': 'Patients will grade satisfaction of treatment by answering "Which side of their face improved more from treatment?" with the option of responding "the right side/the left side/they are the same."'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['perioral dermatitis', 'laser therapy'], 'conditions': ['Perioral Dermatitis']}, 'descriptionModule': {'briefSummary': "Perioral dermatitis is an inflammation of the skin around the mouth. The cause of perioral dermatitis is unknown. Current treatment methods include oral antibiotics and topical calcenurin inhibitors, both of which produce side effects and have been relatively ineffective in the treatment of perioral dermatitis. The investigators hope to assess the efficacy of laser therapy in treatment of perioral dermatitis by using laser therapy on one half of the patients face and having patients apply topical medication (clindamycin) to their face for 8 weeks. The side of their face that receives laser therapy will be randomized. The investigators will assess the efficacy of laser therapy by counting the number of lesions that patients have before and after laser therapy, comparing photos of patient's perioral dermatitis before and after treatment, and having patient's rate their satisfaction of the treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older\n* perioral dermatitis for greater than 1 month\n* willing to return for follow-up visits 2 weeks, 4 weeks and 8 weeks following treatment.\n\nExclusion Criteria:\n\n* skin type V or VI (due to risk of hyperpigmentation)\n* pregnant\n* breastfeeding\n* unable to understand English\n* mentally impaired\n* incarcerated'}, 'identificationModule': {'nctId': 'NCT03779295', 'briefTitle': 'Laser Therapy for Perioral Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'Laser Therapy for Perioral Dermatitis', 'orgStudyIdInfo': {'id': '1803028429'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulse laser therapy', 'description': 'Pulse laser therapy will be randomly applied to right side or left side of face in addition to Clindamycin', 'interventionNames': ['Device: Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.)', 'Drug: Clindamycin']}, {'type': 'EXPERIMENTAL', 'label': 'Clindamycin', 'description': 'Clindamycin only applied to side of face that does not receive pulse laser therapy.', 'interventionNames': ['Drug: Clindamycin']}], 'interventions': [{'name': 'Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.)', 'type': 'DEVICE', 'description': 'The face will be split and randomized, one half will receive pulsed laser dye therapy.', 'armGroupLabels': ['Pulse laser therapy']}, {'name': 'Clindamycin', 'type': 'DRUG', 'description': 'The entire face (both halves) will receive clindamycin.', 'armGroupLabels': ['Clindamycin', 'Pulse laser therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26501', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University University Town Centre Dermatology Clinic', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Erica Ghareeb', 'investigatorAffiliation': 'West Virginia University'}}}}