NCT00483496

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)

Evaluation of the Protection Activity of Microfine Ti02, Pigmentary Ti02 and Bisoctrizole and Their Combinations in Voluntary Patients With SU: Phase II Photoprovocation Test

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Orfagen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Idiopathic Solar Urticaria

Interventions

Type	Name	Description
DRUG	Titanium dioxide (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)

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-06-07
• Last updated: 2017-12-22
• Results posted: 2014-03-31

Locations

3 sites across 2 countries: United States, United Kingdom