Idiopathic Solar UrticariaPhase 2NCT00483496

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)

A Phase 2 study testing Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209), Ti02 pigmentary 3% alone (formula RV3131A-MV1211) and bisoctrizole 10% alone (formula RV3131A-MV1237) in people with Idiopathic Solar Urticaria, run by Orfagen at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Idiopathic Solar Urticaria
What is being tested?: Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209), Ti02 pigmentary 3% alone (formula RV3131A-MV1211) and bisoctrizole 10% alone (formula RV3131A-MV1237)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 3 sitesin 2 countries
Study dates: Sep 2007to Apr 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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 locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United States2 sites

Henry Ford Medical Center
Detroit, Michigan, 48202-2689
St Luke's Roosevelt Hospital Center
New York, New York, 100025

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United Kingdom1 site

Ninewells Hospital
Dundee, DD19SY

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About this study

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

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).

Conditions: Idiopathic Solar Urticaria
Being tested: Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209), Ti02 pigmentary 3% alone (formula RV3131A-MV1211), bisoctrizole 10% alone (formula RV3131A-MV1237), Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213), Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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)Drug

Study groups in NCT00483496
Study group	Role	What they receive
V0096CR actives and vehicle	Experimental	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. Receives: 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: During each one of the 5 sessions, at study day

Secondary outcomes (1)

Adverse Events
Measured: through study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Apr 2008

First posted7 Jun 2007 (estimated)
Study startSep 2007
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Idiopathic Solar UrticariaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00483496
Sponsor's protocol ID: V00096 CR 205 (ORF)
Status last verified: Nov 2017
First submitted: 6 Jun 2007
Last updated: 22 Dec 2017
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00483496
Acronym / sponsor ID: V00096 CR 205 (ORF)
Conditions: Idiopathic Solar Urticaria
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: OrfagenIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 7 Jun 2007 (estimated)
Results: Posted 31 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 1

Arm	Type	Receives
V0096CR actives and vehicle	Experimental	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)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Titanium dioxide (Ti02) microfine 12.15% alone (formula RV3131A-MV1209)	Drug	V0096CR actives and vehicle
Ti02 pigmentary 3% alone (formula RV3131A-MV1211)	Drug	V0096CR actives and vehicle
bisoctrizole 10% alone (formula RV3131A-MV1237)	Drug	V0096CR actives and vehicle
Ti02 microfine 12.15% + Ti02 pigmentary 3% (formula RV3131A-MV1213)	Drug	V0096CR actives and vehicle
Ti02 microfine 12.15% + bisoctrizole 10% (formula RV3131A-MV1329)	Drug	V0096CR actives and vehicle
Ti02 pigmentary 3% + bisoctrizole 10% (formula RV3131A-MV1212)	Drug	V0096CR actives and vehicle
Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% [V0096 CR (formula RV3131A-MV1166)]	Drug	V0096CR actives and vehicle
V0096 CR vehicle (formula RV3131A-MV1197)	Drug	V0096CR actives and vehicle

Primary outcome

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
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.

1 secondary outcome

Adverse Events
Time frame: through study completion

Results and safety

Results posted to the registry on 31 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	16	15

Primary outcome: 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. Mean (Full Range). Unit: Photodermatosis Protection Factor

Measure	V0096 n = 15	Ti02Pig + Bisoctrizole n = 15	TiO2 Micro + Bisoctrizole n = 15	TiO2Pig + TiO2Micro n = 15	Bisoctrizole n = 15	TiO2 Micro n = 15	TiO2Pig n = 15	Vehicle n = 15
Value	4.33 (1.00 to 9.00)	3.93 (1.00 to 9.00)	3.80 (1.00 to 9.00)	3.67 (1.00 to 9.00)	3.53 (1.00 to 9.00)	3.27 (1.00 to 9.00)	2.33 (1.00 to 7.00)	1.93 (1.00 to 3.00)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	0 of 15 (0%)	1 of 15 (6.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick Dupuy, Dr study director

Orfagen

James Ferguson, Pr principal investigator

Ninewells Hospital

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00483496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.