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Evaluation of the Protection Activity of Microfine Ti02, Pigmentary Ti02 and Bisoctrizole and Their Combinations in Voluntary Patients With Idiopathic Solar Urticaria (SU)
This study has been completed.
First Received: June 6, 2007   Last Updated: December 3, 2008   History of Changes
Sponsored by: Orfagen
Information provided by: Orfagen
ClinicalTrials.gov Identifier: NCT00483496
  Purpose

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).


Condition Intervention Phase
Idiopathic Solar Urticaria
Drug: Ti02 microfine 12.15% alone (formula RV3131A-MV1209)
Drug: Ti02 pigmentary 3% alone (formula RV3131A-MV1211)
Drug: bisoctrizole 10% alone (formula RV3131A-MV1237)
Drug: Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213)
Drug: V0096 CR vehicle (formula RV3131A-MV1197)
Drug: Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212)
Drug: Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)]
Drug: Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329)
Phase II

MedlinePlus related topics: Hives
Drug Information available for: Bisoctrizole
U.S. FDA Resources
Study Type: Interventional
Study Design: Factorial Assignment, Open Label, Placebo Control, Randomized
Official Title: Evaluation of the Protection Activity of Microfine Ti02, Pigmentary Ti02 and Bisoctrizole and Their Combinations in Voluntary Patients With Idiopathic Solar Urticaria (SU): Phase II Photoprovocation Test

Further study details as provided by Orfagen:

Study Start Date: September 2007
Estimated Study Completion Date: April 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483496

Locations
United States, Michigan
Henry Ford Medical Center
Detroit, Michigan, United States, 48202-2689
United States, New York
St Luke's Roosevelt Hospital Center
New-York, New York, United States, 100025
United Kingdom
Ninewells Hospital
Dundee, United Kingdom, DD19SY
Sponsors and Collaborators
Orfagen
Investigators
Study Director: Patrick Dupuy, Dr Orfagen
Principal Investigator: James Ferguson, Pr Ninewells Hospital
  More Information

No publications provided

Study ID Numbers: V00096 CR 205 (ORF)
Study First Received: June 6, 2007
Last Updated: December 3, 2008
ClinicalTrials.gov Identifier: NCT00483496     History of Changes
Health Authority: European Union: European Medicines Agency;   United States: Food and Drug Administration

Study placed in the following topic categories:
Hypersensitivity
Skin Diseases
Hypersensitivity, Immediate
Urticaria

Additional relevant MeSH terms:
Hypersensitivity
Skin Diseases, Vascular
Immune System Diseases
Skin Diseases
Hypersensitivity, Immediate
Urticaria

ClinicalTrials.gov processed this record on March 16, 2009