Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT00708851
Status:
COMPLETED
Last Update Posted:
2015-04-20
First Post:
2008-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
NB-UVB Phototherapy With and Without Topical LCD Treatment: a Bilateral Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dreamacres1@aol.com', 'phone': '609-443-4501', 'title': 'Jerry Bagel, MD', 'organization': 'Psoriasis Treatment Center of Central New Jersey'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This is a bilateral pilot study including 12 subjects. Subjects will apply the liquor carbonis distillate (LCD) solution to one half of their body, while receiving narrow-band ultraviolet B (NB-UVB) light therapy across their whole body.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events for this study were monitored and documented throughout the entire 12 week study.', 'description': 'Adverse events were reported directly by the subject to the principal investigator, who then informed the responsible party: NeoStrata Co., Inc.', 'eventGroups': [{'id': 'EG000', 'title': 'NB-UVB Alone', 'description': 'NB-UVB Alone\n\nNB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LCD+NB-UVB', 'description': 'LCD+NB-UVB\n\nLCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day\n\nNB-UVB Phototherapy: 3 light sessions / week', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Erythema', 'notes': 'adverse reaction consisted of one report of mild post-NB-UVB erythema, which appeared uniformly on both sides of the body, regardless of treatment condition.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'notes': 'Treatment-related adverse reactions consisted of two reports of moderate post-UVB erythema which appeared uniformly on both sides of the body.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB-UVB Alone', 'description': 'NB-UVB Alone\n\nNB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week'}, {'id': 'OG001', 'title': 'LCD+NB-UVB', 'description': 'LCD+NB-UVB\n\nLCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day\n\nNB-UVB Phototherapy: 3 light sessions / week'}], 'classes': [{'title': 'Percent Change in PGA score from Baseline', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '85.4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '100'}]}]}, {'title': 'Mean Percent Change in Erythema', 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '88.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Mean Percent Change in Induration', 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '85.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Mean Percent Decrease in Desquamation', 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '82.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks of treatment', 'description': 'Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe).', 'unitOfMeasure': 'percent improvement from baseline', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores we filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.'}, {'type': 'SECONDARY', 'title': 'The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB-UVB Alone', 'description': 'NB-UVB Alone\n\nNB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week'}, {'id': 'OG001', 'title': 'LCD+NB-UVB', 'description': 'LCD+NB-UVB\n\nLCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day\n\nNB-UVB Phototherapy: 3 light sessions / week'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks of treatment', 'description': 'Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores were filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NB-UVB and NB-UVB+LCD', 'description': 'NB-UVB Alone: NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy: 3 light exposures / week\n\nNB-UVB+LCD: 2 applications of LCD/day + NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy 3 light exposures / week'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'NB-UVB Alone', 'description': 'One leg receives NB-UVB Alone: NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week\n\nOpposite leg receives: LCD therapy 2 applications/day and NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy 3 light exposures / week'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.41', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '67'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '12 participants with bilateral, symmetrical plaque psorasis'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-02', 'studyFirstSubmitDate': '2008-06-27', 'resultsFirstSubmitDate': '2014-11-13', 'studyFirstSubmitQcDate': '2008-07-01', 'lastUpdatePostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-02', 'studyFirstPostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions.", 'timeFrame': '12 weeks of treatment', 'description': 'Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe).'}], 'secondaryOutcomes': [{'measure': 'The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.', 'timeFrame': '12 weeks of treatment', 'description': 'Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['psoriasis'], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if combining a daily at-home regimen using an LCD Solution with a 3 times weekly outpatient narrowband UVB phototherapy regimen could be a safe, effective, rapid, and, convenient treatment for plaque psoriasis.', 'detailedDescription': 'Use of coal tar with narrowband (NB) ultraviolet B (UVB) light (the Goeckermen regimen) is an effective treatment for plaque psoriasis that has become impractical in outpatient care mainly due to the inconvenience and aesthetic concerns of coal tar. This study aims to evaluate the safety, efficacy, and convenience of adding a novel liquor carbonis distillate (LCD) (coal tar) solution to standard NB\\_UVB phototherapy in adults with chronic plaque psoriasis. Patients will apply LCD solution to half the body, twice daily at home and receive outpatient full-body NB-UVB light therapy 3 times a week for up to 12 weeks. A blinded investigator will grade psoriasis severity of body halves and bilateral target lesions and monitor adverse reactions. Patients will rate their psoriasis symptoms and LCD solution aesthetics. Incorporating an at-home regimen with a novel LCD solution into outpatient NB-UVB light therapy is safe, convenient, and effective and can improve psoriasis more quickly than NB-UVB light therapy alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older\n* able and willing to provide written informed consent\n* symmetrical plaque psoriasis\n* able and willing to attend phototherapy sessions and apply LCD at home\n* negative pregnancy test for women of child-bearing potential\n\nExclusion Criteria:\n\n* current or recent other treatments for psoriasis\n* hypersensitivity to LCD or UVB light\n* current or previous skin cancer\n* pregnant or nursing mother\n* participating in another clinical trial'}, 'identificationModule': {'nctId': 'NCT00708851', 'briefTitle': 'NB-UVB Phototherapy With and Without Topical LCD Treatment: a Bilateral Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeoStrata Company, Inc.'}, 'officialTitle': 'A Clinical Evaluation of Safety & Efficacy of Adding an At-home Topical LCD Solution Regimen to Standard Narrowband UVB Phototherapy Administered 3 Times Weekly to Adults With Generalized Plaque Psoriasis.', 'orgStudyIdInfo': {'id': '07-LCDUVB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NB-UVB Light Device (311-315 nm)', 'description': 'the subject will receive full body NB-UVB light therapy', 'interventionNames': ['Device: NB-UVB Light Device (311-315 nm)']}, {'type': 'EXPERIMENTAL', 'label': 'LCD Solution with NB-UVB Phototherapy', 'description': 'on half of the body will receive LCD while the full body receives NB-UVB therapy', 'interventionNames': ['Other: LCD Solution with NB-UVB Phototherapy', 'Device: NB-UVB Light Device (311-315 nm)']}], 'interventions': [{'name': 'LCD Solution with NB-UVB Phototherapy', 'type': 'OTHER', 'otherNames': ['LCD'], 'description': 'LCD Solution: 2 applications / day\n\nNB-UVB Phototherapy: 3 light sessions / week', 'armGroupLabels': ['LCD Solution with NB-UVB Phototherapy']}, {'name': 'NB-UVB Light Device (311-315 nm)', 'type': 'DEVICE', 'otherNames': ['Ultralite Model # V4848NB'], 'description': 'NB-UVB Phototherapy: 3 light exposures / week', 'armGroupLabels': ['LCD Solution with NB-UVB Phototherapy', 'NB-UVB Light Device (311-315 nm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Windsor Dermatology', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}], 'overallOfficials': [{'name': 'Jerry Bagel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Windsor Dermatology, East Windsor, NJ 08520'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeoStrata Company, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}