Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT00690833
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2008-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sfeldman@wakehealth.edu', 'phone': '336-716-3775', 'title': 'Dr Steve feldman', 'organization': 'Wake Forest University Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Topical Desonide Hydrogel 0.05%', 'description': 'Approximately 40 male and female subjects (about 20 age 3 months to \\<13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD\n\ntopical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator Global Assessment at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Desonide Hydrogel 0.05%', 'description': 'Approximately 40 male and female subjects (about 20 age 3 months to \\<13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD\n\ntopical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The Investigator global assessment at Week 4 is based on an overall scale of 0-4 with 0 being clear and 4 being very severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topical Desonide Hydrogel 0.05%', 'description': 'Approximately 40 male and female subjects (about 20 age 3 months to \\<13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD\n\ntopical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Topical Desonide Hydrogel 0.05%', 'description': 'Approximately 40 male and female subjects (about 20 age 3 months to \\<13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD\n\ntopical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2008-06-02', 'resultsFirstSubmitDate': '2017-02-08', 'studyFirstSubmitQcDate': '2008-06-02', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-08', 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Global Assessment at Week 4', 'timeFrame': 'Week 4', 'description': 'The Investigator global assessment at Week 4 is based on an overall scale of 0-4 with 0 being clear and 4 being very severe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to better understand how this study drug works when people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug Administration (FDA) for atopic dermatitis.', 'detailedDescription': 'To assess the efficacy of a desonide hydrogel 0.05% in both young children (age \\<13) and older subjects (ages 13 and up) with mild to moderate atopic dermatitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age 3 months or greater.\n* Subjects must have diagnosis of mild to moderate atopic dermatitis by an investigator (a 2 or 3 on the IGA scale).\n* Subjects must have \\>2% BSA involvement to be enrolled.\n* Informed consent of participation must be given by parent or guardian if he or she is \\<7 years old. Children who are 7 to 18 years old will be given an assent form to sign.\n* Moisturizers will be allowed during the study as long as the use remains stable from screening/baseline throughout the study.\n\nExclusion Criteria:\n\n* Known allergy or sensitivity to topical desonide hydrogel in the subject.\n* Inability to complete all study-related visits.\n* Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. Other than stable use of over the counter non-medicated moisturizers, all other topical treatments for AD must be stopped prior to study drug initiation. There will be no required washout for any topical therapies. Stable use of systemic therapies may be continued throughout the study.\n* Requiring \\>130 gm of cream in a 4 week period.\n* Pregnant women and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control. Use of desonide in pregnant subjects is controversial and is only to be used when benefits outweigh the risks.'}, 'identificationModule': {'nctId': 'NCT00690833', 'briefTitle': 'Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'IRB00002928'}, 'secondaryIdInfos': [{'id': '32426'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'topical desonide hydrogel 0.05%', 'description': 'Approximately 40 male and female subjects (about 20 age 3 months to \\<13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD', 'interventionNames': ['Drug: topical desonide hydrogel 0.05%']}], 'interventions': [{'name': 'topical desonide hydrogel 0.05%', 'type': 'DRUG', 'otherNames': ['Desonide gel'], 'description': 'apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions', 'armGroupLabels': ['topical desonide hydrogel 0.05%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences Dermatology', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Steve Feldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}