Trial Outcomes & Findings for Patch Test of Benzalkonium Chloride Disinfectant Spray (NCT NCT01762982)

Results Overview

Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

Baseline to 24 hours following product application

Results posted on

2014-01-22

Participant Flow

Participants were recruited at the clinical site.

Of 37 participants screened, 1 did not meet the study criteria. Remaining 36 were randomized to the study. Two negative controls, one positive control and one test product were used simultaneously and inserted into the patch (Finn chamber patch test device) as it was a 4-way split plot design study.

Participant milestones

Participant milestones
Measure	Overall This was a 4-way split-plot clinical study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 milliliters (mL) of 0.13% Benazalkonium chloride solution), one positive control \[Sodium lauryl sulphate (SLS); 0.03 mL of 0.3% weight by weight (w/w) SLS solution\] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% weight by volume (w/v) normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.
Overall Study STARTED	36
Overall Study Received Saline Water	36
Overall Study Received Benzalkonium Chloride	36
Overall Study Received SLS	36
Overall Study Received Empty Finn Chamber	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patch Test of Benzalkonium Chloride Disinfectant Spray

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomized Participants n=36 Participants All randomized participants were evaluated for baseline parameters.
Age, Continuous	36.2 Years STANDARD_DEVIATION 12.27 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 24 hours following product application

Population: Intention to Treat (ITT) population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment.

Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.