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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V0096CR actives and vehicle | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209) | Drug |
| ||
| Ti02 pigmentary 3% alone (formula RV3131A-MV1211) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During each one of the 5 sessions, at study day |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | through study completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Dupuy, Dr | Orfagen | Study Director |
| James Ferguson, Pr | Ninewells Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Medical Center | Detroit | Michigan | 48202-2689 | United States | ||
| St Luke's Roosevelt Hospital Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Each patient received the 8 test products on the 8 test areas of the randomly allocated grid. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
|
| New York |
| New York |
| 100025 |
| United States |
| Ninewells Hospital | Dundee | DD19SY | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Each patient received the 8 test products on the 8 test areas of the randomly allocated grid. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | Photodermatosis Protection Factor | During each one of the 5 sessions, at study day |
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| Secondary | Adverse Events | Posted | Count of Participants | Participants | through study completion |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Each patient received the 8 test products on the 8 test areas of the randomly allocated grid. | 0 | 15 | 1 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| URTICARIA HEAT | Skin and subcutaneous tissue disorders |
|
Publications relating to the TRIAL and results therefrom are subject to prior mutual agreement of the SPONSOR and the INVESTIGATOR.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical project manager | Orfagen | 0033534506462 | caroline.miklaszewski@orfagen.com |
| ID | Term |
|---|---|
| C009495 | titanium dioxide |
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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| >=65 years |
|
| OG007 |
| 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). |
|