CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209) +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00483496
NCT00483496Phase 2Completed
CompareCT.gov

Evaluation of the Protection Activity of Microfine Ti02, Pigmentary Ti02 and Bisoctrizole and Their Combinations in Voluntary Patients With SU: Phase II Photoprovocation Test

Orfagen·interventional·Posted Jun 7, 2007·Updated Dec 22, 2017

In Brief

A Phase 2 clinical trial evaluating Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209), Ti02 pigmentary 3% alone (formula RV3131A-MV1211), and 6 other interventions for Idiopathic Solar Urticaria. Completed, enrolled 16 participants across 3 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Solar Urticaria
CountriesUnited Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 7, 2007
Enrollment StartSep 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 19.1 years ago

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