Conditions: Idiopathic Solar Urticaria
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 16
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209) intervention 2: Ti02 pigmentary 3% alone (formula RV3131A-MV1211) intervention 3: bisoctrizole 10% alone (formula RV3131A-MV1237) intervention 4: Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213) intervention 5: Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329) intervention 6: Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212) intervention 7: Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)] intervention 8: V0096 CR vehicle (formula RV3131A-MV1197)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None

Protocol document: