Idiopathic Solar Urticaria (SU)
Conditions
Interventions
Product Code: V0096 CR (formula RV3131A-MV1166)
Pharmaceutical Form: Cream
Other descriptive name: Tinosorb™ M (aqueous dispersion of Tinosorb MBBT)
Concentration unit: % (W/W) percent weight/weight
C
Sponsors
ORFAGEN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female voluntary patients of at least 18 years old For female patients with a 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 providing that these conditions are stable and under control Patients able to follow instructions Written informed consent from the patients Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 External Photoprotector (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, antiinflammatories 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 |
|---|---|
| Main Objective: To compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, Tinosorb MBBT) and their respective combinations.;Secondary Objective: To assess the local tolerance and adverse events of the test formulations after one single application.;Primary end point(s): Assessment of the MUD on each test site, after application of the test products. MUD will be defined as the minimal dose for occurrence of objective signs of SU (wheal, flare) under exposure to the solar simulator. Results will be 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. | — |
Countries
United Kingdom
Outcome results
None listed