Trial record 6 of 50 for:    physical | urticaria

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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orfagen
ClinicalTrials.gov Identifier:
NCT00483496
First received: June 6, 2007
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Idiopathic Solar Urticaria
Drug: Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209)
Drug: Ti02 pigmentary 3% alone (formula RV3131A-MV1211)
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)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Protection Activity of Microfine Ti02, Pigmentary Ti02 and Bisoctrizole and Their Combinations in Voluntary Patients With SU: Phase II Photoprovocation Test

Resource links provided by NLM:


Further study details as provided by Orfagen:

Primary Outcome Measures:
  • Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products [ Time Frame: During each one of the 5 sessions, at study day ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Adverse Events [ Time Frame: all over the study ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V0096CR actives and 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).

Single application of the test materials at the dosage of 2mg/cm² (total of 8 treated sites), prior to irradiation using a solar simulator.

Drug: Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209) Drug: Ti02 pigmentary 3% alone (formula RV3131A-MV1211) 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483496

Locations
United States, Michigan
Henry Ford Medical Center
Detroit, Michigan, United States, 48202-2689
United States, New York
St Luke's Roosevelt Hospital Center
New-York, New York, United States, 100025
United Kingdom
Ninewells Hospital
Dundee, United Kingdom, DD19SY
Sponsors and Collaborators
Orfagen
Investigators
Study Director: Patrick Dupuy, Dr Orfagen
Principal Investigator: James Ferguson, Pr Ninewells Hospital
  More Information

No publications provided

Responsible Party: Orfagen
ClinicalTrials.gov Identifier: NCT00483496     History of Changes
Other Study ID Numbers: V00096 CR 205 (ORF)
Study First Received: June 6, 2007
Results First Received: December 19, 2013
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Titanium dioxide
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Photosensitizing Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014