Evaluation of the Protection Activity of Microfine Titanium Dioxide (Ti02), Pigmentary Ti02 and Bisoctrizole and Their Combinations in Voluntary Patients With Idiopathic Solar Urticaria (SU)
NCT ID: NCT00483496
Last Updated: 2017-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2007-09-30
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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V0096CR actives and vehicle
Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
Single application of the test materials at the dosage of 2mg/cm² (total of 8 treated sites), prior to irradiation using a solar simulator.
Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209)
Ti02 pigmentary 3% alone (formula RV3131A-MV1211)
bisoctrizole 10% alone (formula RV3131A-MV1237)
Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213)
Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329)
Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212)
Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)]
V0096 CR vehicle (formula RV3131A-MV1197)
Interventions
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Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209)
Ti02 pigmentary 3% alone (formula RV3131A-MV1211)
bisoctrizole 10% alone (formula RV3131A-MV1237)
Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213)
Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329)
Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212)
Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)]
V0096 CR vehicle (formula RV3131A-MV1197)
Eligibility Criteria
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Inclusion Criteria
* For female patients with child-bearing potential, negative pregnancy test at baseline
* Patients with a clinical and photobiological diagnosis of idiopathic SU
* Patients with no underlying condition, or with underlying conditions provided that these conditions are stable and under control
* Patients able to follow instructions
* Written informed consent from the patients
Exclusion Criteria
* Pregnant or lactating women
* Women with a positive pregnancy test at baseline
* Patients with spontaneous occurrence of SU lesions on the back within 3 days prior to study entry
* Patients with a known allergy to one of the ingredients contained in the test products
* Patients who have applied EP to back skin over the previous 2 weeks before study entry
* Patients who have applied topical corticosteroids to back skin within 7 days prior to study entry
* Patients who have applied an emollient including white soft paraffin on back skin within 2 days prior to study entry
* Patients with systemic exposure to corticosteroids, anti-inflammatories or other immunosuppressive agents within the last 4 weeks prior to study entry
* Patients with oral antihistamines within the last 2 days prior to study entry
* Patients who have been administered systemic or topical photoactive medications for phototherapy or phototherapy alone within 1 week prior to study entry
* Patients with an unstable or non-controlled underlying condition
* Patients who are not able to follow instructions
* Patients who have participated in a study within the 3 months prior to study entry
* Patients who refuse to give written informed consent
18 Years
ALL
No
Sponsors
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Orfagen
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick Dupuy, Dr
Role: STUDY_DIRECTOR
Orfagen
James Ferguson, Pr
Role: PRINCIPAL_INVESTIGATOR
Ninewells Hospital
Locations
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Henry Ford Medical Center
Detroit, Michigan, United States
St Luke's Roosevelt Hospital Center
New York, New York, United States
Ninewells Hospital
Dundee, , United Kingdom
Countries
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Other Identifiers
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V00096 CR 205 (ORF)
Identifier Type: -
Identifier Source: org_study_id