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.
Sponsor:
Orfagen
Information provided by:
Orfagen
ClinicalTrials.gov Identifier:
NCT00483496
First received: June 6, 2007
Last updated: December 3, 2008
Last verified: December 2008
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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: Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329) 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: V0096 CR vehicle (formula RV3131A-MV1197) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
Further study details as provided by Orfagen:
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
| ClinicalTrials.gov Identifier: | NCT00483496 History of Changes |
| Other Study ID Numbers: | V00096 CR 205 (ORF) |
| Study First Received: | June 6, 2007 |
| Last Updated: | December 3, 2008 |
| Health Authority: | United States: Food and Drug Administration European Union: European Medicines Agency |
Additional relevant MeSH terms:
|
Urticaria Skin Diseases, Vascular Skin Diseases |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013