Atopic Dermatitis Clinical Trial
Official title:
Efficacy of 0.005% Sodium Hypochlorite Final Rinse Solution on the Reduction of Staphylococcus Aureus Colonization in Atopic Dermatitis: A Randomized Controlled Trial
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..
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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