|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Orfagen |
|---|---|
| Information provided by: | Orfagen |
| ClinicalTrials.gov Identifier: | NCT00483496 |
Purpose
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 |
|---|---|---|
|
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: Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329) 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: V0096 CR vehicle (formula RV3131A-MV1197) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00483496 History of Changes |
| Other Study ID Numbers: | V00096 CR 205 (ORF) |
| Study First Received: | June 6, 2007 |
| Last Updated: | December 3, 2008 |
| Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
|
Urticaria Skin Diseases, Vascular Skin Diseases |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |