Idiopathic Solar Urticaria
Conditions
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).
Interventions
DRUGbisoctrizole 10% alone (formula RV3131A-MV1237)
DRUGTitanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209)
DRUGTi02 pigmentary 3% alone (formula RV3131A-MV1211)
DRUGTi02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213)
DRUGTi02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329)
DRUGTi02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212)
DRUGTi02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)]
DRUGV0096 CR vehicle (formula RV3131A-MV1197)
Sponsors
Orfagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events | through study completion |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Each patient received the 8 test products on the 8 test areas of the randomly allocated grid. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 50.2 years |
| Region of Enrollment United Kingdom | 5 participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: During each one of the 5 sessions, at study day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| V0096 | Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products | 4.33 Photodermatosis Protection Factor |
| Ti02Pig + Bisoctrizole | Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products | 3.93 Photodermatosis Protection Factor |
| TiO2 Micro + Bisoctrizole | Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products | 3.80 Photodermatosis Protection Factor |
| TiO2Pig + TiO2Micro | Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products | 3.67 Photodermatosis Protection Factor |
| Bisoctrizole | Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products | 3.53 Photodermatosis Protection Factor |
| TiO2 Micro | Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products | 3.27 Photodermatosis Protection Factor |
| TiO2Pig | Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products | 2.33 Photodermatosis Protection Factor |
| Vehicle | Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products | 1.93 Photodermatosis Protection Factor |
Secondary
Adverse Events
Time frame: through study completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| V0096 | Adverse Events | 1 Participants |