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)

Completed · Phase 2

Conditions studied: Idiopathic Solar Urticaria

In brief

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).

Key facts

Study ID: NCT00483496
Run by: Orfagen
People needed: 16
Starts: 2007-09-01
Expected to finish: 2008-04-01
Last updated by the study team: 2017-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Henry Ford Medical Center — Detroit, Michigan, United States
St Luke's Roosevelt Hospital Center — New York, New York, United States
Ninewells Hospital — Dundee, United Kingdom

Full record on ClinicalTrials.gov

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