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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)

NCT00483496 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-12-22

Study results available
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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).

Conditions

  • Idiopathic Solar Urticaria

Interventions

DRUG

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)

Sponsors & Collaborators

  • Orfagen

    lead INDUSTRY

Principal Investigators

  • Patrick Dupuy, Dr · Orfagen

  • James Ferguson, Pr · Ninewells Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00483496 on ClinicalTrials.gov