Back to resultsEvaluation of the Protection Activity of Microfine Titanium Dioxide (Ti02), Pigmentary Ti02 and Bisoctrizole and Their Combinations in Voluntary Patients With Idiopathic Solar Urticaria (SU)
Primary Purpose
Idiopathic Solar Urticaria
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209)
Ti02 pigmentary 3% alone (formula RV3131A-MV1211)
bisoctrizole 10% alone (formula RV3131A-MV1237)
Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213)
Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329)
Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212)
Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)]
V0096 CR vehicle (formula RV3131A-MV1197)
Sponsored by
About this trial
This is an interventional supportive care trial for Idiopathic Solar Urticaria
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
Sites / Locations
- Henry Ford Medical Center
- St Luke's Roosevelt Hospital Center
- Ninewells Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
V0096CR actives and vehicle
Arm Description
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.
Outcomes
Primary Outcome Measures
Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products
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.
Secondary Outcome Measures
Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00483496
Brief Title
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)
Official Title
Evaluation of the Protection Activity of Microfine Ti02, Pigmentary Ti02 and Bisoctrizole and Their Combinations in Voluntary Patients With SU: Phase II Photoprovocation Test
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orfagen
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Solar Urticaria
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
V0096CR actives and vehicle
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209)
Intervention Type
Drug
Intervention Name(s)
Ti02 pigmentary 3% alone (formula RV3131A-MV1211)
Intervention Type
Drug
Intervention Name(s)
bisoctrizole 10% alone (formula RV3131A-MV1237)
Intervention Type
Drug
Intervention Name(s)
Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213)
Intervention Type
Drug
Intervention Name(s)
Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329)
Intervention Type
Drug
Intervention Name(s)
Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212)
Intervention Type
Drug
Intervention Name(s)
Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)]
Intervention Type
Drug
Intervention Name(s)
V0096 CR vehicle (formula RV3131A-MV1197)
Primary Outcome Measure Information:
Title
Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products
Description
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.
Time Frame
During each one of the 5 sessions, at study day
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
through study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Dupuy, Dr
Organizational Affiliation
Orfagen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
James Ferguson, Pr
Organizational Affiliation
Ninewells Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
Facility Name
St Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
100025
Country
United States
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD19SY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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)
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