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)

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orfagen
• Treatments: Titanium dioxide

Criteria

Inclusion Criteria:

• Male or female voluntary patients at least 18 years old

• 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:

• Children (less than 18 years old)

• 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