Phase 2
Completed 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
Source: ClinicalTrials.gov NCT00483496 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: 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
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).
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 | — |
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. Informational only — not medical advice.