Clinical trial NCT00483496: 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)
Official title: Evaluation of the Protection Activity of Microfine Ti02, Pigmentary Ti02 and Bisoctrizole and Their Combinations in Voluntary Patients With SU: Phase II Photoprovocation Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Solar Urticaria
Lead sponsor: Orfagen
Sponsor class: INDUSTRY
First posted: 2007-06-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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).


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

Primary outcomes:
measure: Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products
timeFrame: During each one of the 5 sessions, at study day
Secondary outcomes:
measure: Adverse Events
timeFrame: through study completion
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: New York
country: United States
facility: St Luke's Roosevelt Hospital Center
state: New York
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
Study officials:
affiliation: Orfagen
name: Patrick Dupuy, Dr
role: STUDY_DIRECTOR
affiliation: Ninewells Hospital
name: James Ferguson, Pr
role: PRINCIPAL_INVESTIGATOR
References: