Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-07 @ 5:37 AM
Study NCT ID:
NCT01826461
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2013-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2013-04-01', 'studyFirstSubmitQcDate': '2013-04-03', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Eczema Area and Severity Index (EASI) Score', 'timeFrame': 'Baseline and Day 29', 'description': 'Percent change from Baseline in EASI scores at Day 29. EASI excludes non-key signs of eczema (such as xerosis and scaling, oozing and crusting), and subjective parameters (such as pruritus and sleep loss) in order to focus the index on key disease signs and to avoid mixing objective parameters with subjective symptoms. EASI scores range from 0 (least severe) to 72 (most severe).'}, {'measure': 'Change in Body Surface Area (BSA) Affected', 'timeFrame': 'Baseline, Days 8, 15 and 29', 'description': 'Percent change from Baseline in the percent BSA affected by disease at Days 8, 15 and 29.'}, {'measure': 'Change in Clinical Signs of Atopic Dermatitis (AD)', 'timeFrame': 'Baseline and Days 8, 15 and 29', 'description': 'Change from Baseline in severity of erythema, induration/papulation, excoriation, lichenification and oozing/crusting at Days 8, 15, and 29. All clinical signs are evaluated on a 4-point ordinal scale from 0 (none) to 3 (severe).'}, {'measure': 'Change in Pruritis Severity at Days 8 and 15', 'timeFrame': 'Baseline and Days 8 and 15', 'description': 'Change from Baseline in the severity of pruritus (itching) at Days 8 and 15. Pruritis severity is based on a periodic subject assessment using a 4-point ordinal scale from 0 = none to 3 = severe.'}, {'measure': 'Subject Assessment of Improvement in Atopic Dermatitis', 'timeFrame': 'Day 29', 'description': 'Subject global assessment of improvement in AD at Day 29, based on a 5-point ordinal scale from 1 (excellent improvement) to 5 (worse).'}], 'primaryOutcomes': [{'measure': '"Treatment Success" based on change in Investigator\'s Global Assessment (IGA)', 'timeFrame': 'Baseline and Day 29', 'description': 'Success rate, based on IGA score. Success rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and at least a 2-grade improvement from Baseline on the IGA score at Day 29. IGA is a measure of overall severity of atopic dermatitis using a 5-point ordinal scale from 0 = clear to 4 = severe.'}], 'secondaryOutcomes': [{'measure': 'Change in Pruritis Severity at Day 29', 'timeFrame': 'Baseline and Day 29', 'description': 'Change from Baseline in the severity of pruritus (itching) at Day 29. Pruritis severity is based on a periodic subject assessment using a 4-point ordinal scale from 0 = none to 3 = severe.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'eczema', 'PDI-192', 'Precision'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This study will compare the safety and efficacy of three test article foams (PDI-192 0.1% Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be selected for future development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject presents with a clinical diagnosis of stable mild to moderate atopic dermatitis.\n* Subject has used the same type of soap, moisturizers, lotions, creams, ointments, sunscreens or other skin products, and hair products (shampoo, etc.) for at least two weeks prior to study start and agrees to continue usage with the same products and with similar frequency for the entire study.\n\nExclusion Criteria:\n\n* Subject is pregnant, lactating or is planning to become pregnant during the study.\n* Subject requires any topical or systemic medications or is using topical inflammatory dermatoses therapies that could affect the course of their atopic dermatitis during the study period.\n* Subject has used systemic corticosteroids, immunomodulators including leukotriene inhibitors, or antimetabolites within 30 days prior to study start.\n* Subject has used Ultraviolet Light Therapy (PUVA, UVB, etc.) within 30 days prior to study start.\n* Subject has used topical therapies for the treatment of (or may affect) their atopic dermatitis including but not limited to corticosteroids, immunomodulators (tacrolimus, pimecrolimus, etc.), tar, calcipotriene or other vitamin D preparations, retinoids, antihistamines (doxepin, diphenhydramine, etc.), antibiotics, among others, within 14 days prior to study start.\n* Subject desires excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) during the study.\n* Subject has used systemic (oral, IV, etc.) antibiotic therapy within seven days prior to study start.\n* Subject is currently enrolled in an investigational drug or device study.\n* Subject has used an investigational drug or investigational device treatment within 30 days prior to study start.'}, 'identificationModule': {'nctId': 'NCT01826461', 'briefTitle': 'An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'PreCision Dermatology, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Evaluation of Twice Daily PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis in Subjects 3 Months to Less Than 18 Years of Age', 'orgStudyIdInfo': {'id': '172-0151-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PDI-192 Foam, 0.1%', 'description': 'topical foam, 0.1% concentration, twice daily', 'interventionNames': ['Drug: PDI-192']}, {'type': 'EXPERIMENTAL', 'label': 'PDI-192 Foam, 0.15%', 'description': 'topical foam, 0.15% concentration, twice daily', 'interventionNames': ['Drug: PDI-192']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Foam', 'description': 'topical foam, 0% concentration, twice daily', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'PDI-192', 'type': 'DRUG', 'armGroupLabels': ['PDI-192 Foam, 0.1%', 'PDI-192 Foam, 0.15%']}, {'name': 'Vehicle', 'type': 'DRUG', 'armGroupLabels': ['Vehicle Foam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "UCSD - Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Sneeze, Wheeze & Itch Associates, LLC', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Academic Dermatology Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology Consulting Services', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Houston Health Science Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Clinical Research, Inc.', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Syd Dromgoole, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PreCision Dermatology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}