0.005% Sodium Hypochlorite Final Rinse Solution in Atopic Dermatitis

NCT ID: NCT02241174

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-02-28

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sodium Hypochlorite

Intervention Type: DRUG

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

Placebo

100ml distilled water will be used as a placebo and will be stored on amber bottles identical with the treatment group

Group Type: PLACEBO_COMPARATOR

Sodium Hypochlorite

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Makati Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jamaine Cruz, MD

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donna Marie L. Sarrosa, MD, FPDS

Role: PRINCIPAL_INVESTIGATOR

Makati Medical Center

Jamaine Melisse L Cruz, MD

Role: PRINCIPAL_INVESTIGATOR

Makati Medical Center

Locations

Makati Medical Center

Makati, NCR, Philippines

Countries

Philippines

Other Identifiers

SodiumHypochloriteAD

Identifier Type: -

Identifier Source: org_study_id