NCT02241174

0.005% Sodium Hypochlorite Final Rinse Solution in Atopic Dermatitis

Efficacy of 0.005% Sodium Hypochlorite Final Rinse Solution on the Reduction of Staphylococcus Aureus Colonization in Atopic Dermatitis: A Randomized Controlled Trial

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Makati Medical Center · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Accepted

Summary

This study will determine the safety and efficacy of diluted bleach bath solution as final rinse on the reduction of Staphylococcus aureus colonization among children and adult Filipinos with mild to moderate atopic dermatitis..

Detailed description

Objective: To determine the safety and efficacy of 0.005% sodium hypochlorite final rinse solution on the reduction of Staphylococcus aureus colonization among children and adult Filipinos with mild to moderate atopic dermatitis. Design: Randomized, double blind, controlled clinical trial. Setting: Makati Medical Center, Dermatology Outpatient Department Participants: Patients with mild to moderate atopic dermatitis, seen at Makati Medical Center Dermatology Outpatient Department. Sample size: 68 (34 treatment group, 34 placebo group) Intervention: Eligible patients will be randomly allocated to two groups. The subjects will either be in the treatment group (0.005% sodium hypochlorite) or in the placebo group (bath water). Subjects will use a liter of 0.005% sodium hypochlorite as a final rinse solution during bathing for the treatment group and a liter of bath water for the placebo group. This intervention will be done twice a week for 12 weeks. Both patients and assessors will be blinded to the treatment assignments. Assessment of Outcome: The outcomes will be assessed at weeks 4 and 12. Primary outcome measure will use culture findings, physician's global assessment (PGA) of severity of disease and eczema area and severity index (EASI) score. Secondary outcome measure will assess adverse effects during follow-up at weeks 4 and 12. Data Analysis: Kruskal-Wallis Test will be used to compare the significant difference in scores between the two groups and Wilcoxon Signed Rank Test will be used to compare significant difference of before and after scores within each group.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Sodium Hypochlorite	The 0.005% sodium hypochlorite solutions will be prepared from the commercially available Clorox® at 6% solution. 0.83ml of the 6% sodium hypochlorite solution will be taken and incorporated to a-100ml absolute distilled water. This 100ml solution will be stored in an amber glass bottle at room temperature unexposed to light at a maximum of 23 months

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-12-01
• Completion: 2015-02-01
• First posted: 2014-09-16
• Last updated: 2015-10-20

Locations

1 site across 1 country: Philippines