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)

Orfagen

Status and phase

Completed

Phase 2

Conditions

Idiopathic Solar Urticaria

Treatments

Drug: Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213)

Drug: Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209)

Drug: V0096 CR vehicle (formula RV3131A-MV1197)

Drug: Ti02 pigmentary 3% alone (formula RV3131A-MV1211)

Drug: Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)]

Drug: Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212)

Drug: bisoctrizole 10% alone (formula RV3131A-MV1237)

Drug: Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00483496

V00096 CR 205 (ORF)

Details and patient eligibility

About

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).

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

16 participants in 1 patient group

V0096CR actives and vehicle

Experimental group

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.

Treatment: