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 |
---|---|
Conditions: | Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/24/2017 |
Start Date: | September 2007 |
End Date: | April 2008 |
Evaluation of the Protection Activity of Microfine Ti02, Pigmentary Ti02 and Bisoctrizole and Their Combinations in Voluntary Patients With SU: Phase II Photoprovocation Test
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).
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).
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
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St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
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