Evaluation of the protection activity of microfine Ti02, pigmentary Ti02 and bisoctrizole and their combinations in voluntary patients with idiopathic solar urticaria (SU): phase II photoprovocation test.

• Conditions: Idiopathic Solar Urticaria (SU)

• Registration Number: EUCTR2007-000911-27-GB
• Lead Sponsor: ORFAGE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-15
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 14

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.