Clinical trial NCT02241174: 0.005% Sodium Hypochlorite Final Rinse Solution in Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Lead sponsor: Makati Medical Center
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Males and females more than 8 years old.
2. Subjects with clinical diagnosis of atopic dermatitis (based on Hannifin and Rajka criteria).
3. Healthy subjects with no other skin disease.
4. Subjects without any prior topical or oral antibiotic two weeks prior to the enrollment period. Those who had undergone course of topical and oral antibiotic are given at least 2 weeks washout period.

Exclusion Criteria:

1. Severe Atopic dermatitis requiring hospitalization.
2. Hospitalized and debilitated patients.
3. Subjects with other serious skin disorder, pigmentation or extensive scarring in affected areas.
4. Subjects who have a known history or clinically relevant allergy, in particular to chlorine containing compounds.
5. Pregnant women and nursing mothers.
6. Subjects who are in a situation, which, in the opinion of the investigator, may interfere with optimal participation in the study.
7. Subjects participating or having participated in a clinical trial within 1 month before enrollment in the study.
8. Subjects who cannot communicate with the investigator (\>18 years old) or are unaccompanied by parent or legal guardian (\<18 years old).
9. Subjects who are unable to follow-up.

Primary outcomes:
measure: Culture and sensitivity findings
timeFrame: 12 weeks
measure: Eczema Assessment Severity Index (EASI)
timeFrame: 12 weeks
measure: Physician Global Assessment (PGA) Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Adverse Effect
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Makati
country: Philippines
facility: Makati Medical Center
state: NCR
Study officials:
affiliation: Makati Medical Center
name: Donna Marie L. Sarrosa, MD, FPDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Makati Medical Center
name: Jamaine Melisse L Cruz, MD
role: PRINCIPAL_INVESTIGATOR
References: