Conditions: Wound Healing
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: yes

Brief summary:
The aim of the study is to evaluate the irritation potential of benzalkonium chloride disinfectant spray when placed in contact with normal human skin.

Detailed description:
Benzalkonium chloride is recognized as safe and effective for short term use as first aid antiseptic drug products. In this study, benzalkonium chloride disinfectant spray will be compared to a positive control, and two negative control for irritancy potential on normal skin according to Chinese Patch Test Guideline (China Health Authority 2002). The skin irritation assessment will characterize the test products individually in terms of symptomatology using a 5-point categorical scale ranging from 0 (no visible reaction) to 4 (Erythema,edema˛ extreme blistering).

Arms:
arm 1: Benzalkonium chloride (0.13%) Disinfectant Spray water arm 2: Sodium lauryl sulfate (SLS) (0.3% weight by weight \[w/w\]) water solution arm 3: Normal saline water (0.9% weight by volume \[w/v\]) arm 4: Empty Finn Chamber

Interventions: intervention 1: 0.13% Benzalkonium Chloride intervention 2: SLS Solution intervention 3: Normal Saline Water intervention 4: Empty Finn Chamber
Intervention descriptions: intervention 1: Finn Chamber filled with benzalkonium chloride (0.13%) disinfectant spray water solution intervention 2: Finn Chamber filled with SLS (0.3% w/v) water solution intervention 3: Finn Chamber filled with Normal Saline water (0.9% w/v) intervention 4: Empty Finn Chamber

Protocol document: