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)
Condition: Idiopathic Solar Urticaria
MeSH terms: Urticaria; Urticaria, Solar
Intervention: Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209); Ti02 pigmentary 3% alone (formula RV3131A-MV1211); bisoctrizole 10% alone (formula RV3131A-MV1237); Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213); Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329); Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212); Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)]; V0096 CR vehicle (formula RV3131A-MV1197)
Intervention MeSH terms: Titanium dioxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility 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