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)

November 24, 2017 updated by: Orfagen

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Dundee, United Kingdom, DD19SY
        • Ninewells Hospital
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
        • Henry Ford Medical Center
    • New York
      • New York, New York, United States, 100025
        • St Luke's Roosevelt Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: V0096CR actives and vehicle

Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).

Single application of the test materials at the dosage of 2mg/cm² (total of 8 treated sites), prior to irradiation using a solar simulator.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products
Time Frame: During each one of the 5 sessions, at study day

MUD was defined as the minimal dose for occurrence of objective signs of SU (wheal, flare) under exposure to the solar simulator. Results are expressed as photodermatosis protection factor (PPF), calculated by dividing the MUD of protected skin (sessions 2 to 5) by the MUD of the unprotected skin (session 1) in each treatment group.

Procedure: At baseline, 4 grids of 8 adjacent test areas on the patient back were defined. The defined test areas of each grid were applied with the respective test products by the investigating staff at the beginning of each session, according to a predefined randomisation schedule. Grids were sequentially irradiated one by one with 1 MUD (session 2) , 3 MUD (session 3) , 5 MUD (session 4), and 7 MUD (session 5), respectively. After product removal at each session, patients were observed for 30 min for the development of SU lesions. Final reading of all areas was performed at the end of each session, by the investigator masked to product site assignment.
During each one of the 5 sessions, at study day

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: through study completion
through study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orfagen

Investigators

  • Study Director: Patrick Dupuy, Dr, Orfagen
  • Principal Investigator: James Ferguson, Pr, Ninewells Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

June 6, 2007

First Submitted That Met QC Criteria

June 6, 2007

First Posted (Estimate)

June 7, 2007

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

November 24, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V00096 CR 205 (ORF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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