Trial Outcomes & Findings for 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) (NCT NCT00483496)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

During each one of the 5 sessions, at study day

Results posted on

2017-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=15 Participants Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
Age, Continuous	50.2 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Region of Enrollment United Kingdom	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	V0096 n=15 Participants 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).	Ti02Pig + Bisoctrizole n=15 Participants 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).	TiO2 Micro + Bisoctrizole n=15 Participants 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).	TiO2Pig + TiO2Micro n=15 Participants 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).	Bisoctrizole n=15 Participants 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).	TiO2 Micro n=15 Participants 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).	TiO2Pig n=15 Participants 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).	Vehicle n=15 Participants 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).
Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products	4.33 Photodermatosis Protection Factor Interval 1.0 to 9.0	3.93 Photodermatosis Protection Factor Interval 1.0 to 9.0	3.80 Photodermatosis Protection Factor Interval 1.0 to 9.0	3.67 Photodermatosis Protection Factor Interval 1.0 to 9.0	3.53 Photodermatosis Protection Factor Interval 1.0 to 9.0	3.27 Photodermatosis Protection Factor Interval 1.0 to 9.0	2.33 Photodermatosis Protection Factor Interval 1.0 to 7.0	1.93 Photodermatosis Protection Factor Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: through study completion

Outcome measures

Outcome measures
Measure	V0096 n=15 Participants 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).	Ti02Pig + Bisoctrizole 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).	TiO2 Micro + Bisoctrizole 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).	TiO2Pig + TiO2Micro 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).	Bisoctrizole 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).	TiO2 Micro 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).	TiO2Pig 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).	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).
Adverse Events	1 Participants	—	—	—	—	—	—	—

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental n=15 participants at risk Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
Skin and subcutaneous tissue disorders URTICARIA HEAT	6.7% 1/15

Additional Information

Clinical project manager

Orfagen

Phone: 0033534506462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publications relating to the TRIAL and results therefrom are subject to prior mutual agreement of the SPONSOR and the INVESTIGATOR.
Publication restrictions are in place

Restriction type: OTHER