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Sponsored by: |
Orfagen |
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Information provided by: | Orfagen |
ClinicalTrials.gov Identifier: | NCT00483496 |
Commercially available external photoprotectors (EP) do not provide adequate protection against ultraviolet A (UVA) and visible wavelengths. The proposed medicinal product V0096 CR (formula RV3131A-MV1166) is a broad spectrum EP (bsEP). The rationale for the use of V0096 CR (formula RV3131A-MV1166) in the proposed condition is based on its ability to broadly block the UVA radiations and visible light that are known to trigger solar urticaria (SU).
Condition | Intervention | Phase |
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Idiopathic Solar Urticaria |
Drug: Ti02 microfine 12.15% alone (formula RV3131A-MV1209) Drug: Ti02 pigmentary 3% alone (formula RV3131A-MV1211) Drug: bisoctrizole 10% alone (formula RV3131A-MV1237) Drug: Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213) Drug: V0096 CR vehicle (formula RV3131A-MV1197) Drug: Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212) Drug: Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)] Drug: Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329) |
Phase II |
Study Type: | Interventional |
Study Design: | Factorial Assignment, Open Label, Placebo Control, Randomized |
Official Title: | Evaluation of the Protection Activity of Microfine Ti02, Pigmentary Ti02 and Bisoctrizole and Their Combinations in Voluntary Patients With Idiopathic Solar Urticaria (SU): Phase II Photoprovocation Test |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
Henry Ford Medical Center | |
Detroit, Michigan, United States, 48202-2689 | |
United States, New York | |
St Luke's Roosevelt Hospital Center | |
New-York, New York, United States, 100025 | |
United Kingdom | |
Ninewells Hospital | |
Dundee, United Kingdom, DD19SY |
Study Director: | Patrick Dupuy, Dr | Orfagen |
Principal Investigator: | James Ferguson, Pr | Ninewells Hospital |
Study ID Numbers: | V00096 CR 205 (ORF) |
Study First Received: | June 6, 2007 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00483496 History of Changes |
Health Authority: | European Union: European Medicines Agency; United States: Food and Drug Administration |
Hypersensitivity Skin Diseases Hypersensitivity, Immediate Urticaria |
Hypersensitivity Skin Diseases, Vascular Immune System Diseases |
Skin Diseases Hypersensitivity, Immediate Urticaria |