Phase 2
N=16
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)
Idiopathic Solar Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT00483496 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products — 4.33; 3.93; 3.80; 3.67 Photodermatosis Protection Factor
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Titanium dioxide (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) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Orfagen
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products |
4.33; 3.93; 3.80; 3.67; 3.53; 3.27 | — |
| SECONDARY Adverse Events |
1 | — |
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
Data sourced from ClinicalTrials.gov (NCT00483496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.