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

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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).


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
We found this trial at
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Detroit, Michigan 48202
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1111 Amsterdam Ave
New York, New York 10025
(212) 523-4000
St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
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Dundee, DD2 1SY
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