0.005% Sodium Hypochlorite Final Rinse Solution in Atopic Dermatitis

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02241174
• Other study ID #: SodiumHypochloriteAD
• Status: Withdrawn
• Phase: Phase 1
• First received: September 12, 2014
• Last updated: October 19, 2015
• Start date: July 2014
• Est. completion date: February 2015

Study information

• Verified date: October 2015
• Source: Makati Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Ethics Committee
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
Philippines	Makati Medical Center	Makati	NCR

Sponsors (1)

Lead Sponsor	Collaborator
Makati Medical Center

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Culture and sensitivity findings	The primary outcome of interest is the reduction of S. aureus colonization in skin lesion and the clinical improvement at week 4 and week 12.	12 weeks	No
Primary	Eczema Assessment Severity Index (EASI)	Clinical decrease in the disease severity of atopic dermatitis Eczema Assessment Severity Index (EASI) b. Clinical decrease in the disease severity of atopic dermatitis Eczema Assessment Severity Index (EASI); Body regions to be assessed: Head/Neck; Upper extremities; Trunk; Lower extremities; In each of the body areas, the following key signs will be assessed: Erythema (E); Induration (I); Excoriation (Ex); Lichenification (L); Scoring from the above features: 0 - none; 1 - mild; 2 - moderate; 3 - severe; Body Surface Area involvement score: 0 = no eruption; 1 = <10%; 2 = 10%-29%; 3 = 30% - 49%; 4 = 50% - 69%; 5 = 70% - 89%; 6 = 90% - 100%; EASI Score Body region EASI Score Head/neck (E + I + Ex + L) x Area x 0.1 Upper extremities (E + I + Ex + L) x Area x 0.2 Trunk (E + I + Ex + L) x Area x 0.3 Lower extremities (E + I + Ex + L) x Area x 0.4 EASI Sum of above scores	12 weeks	No
Primary	Physician Global Assessment (PGA) Scale	Severity of disease at baseline; Mild: Moderate: Severe: Rating scale for PGA of Clinical Response at the end of the treatment; Rating % Improvement Week 4 Week 12; Cleared 100%; Excellent improvement 90-99%; Marked improvement 75-89%; Moderate improvement 50-74%; Slight improvement 30-49% No appreciable improvement 0-29%	12 weeks	No
Secondary	Adverse Effect	An adverse effect is an adverse event for which the causal relation between the intervention and the event is at least a reasonable possibility. The term 'adverse effect' applies to all interventions, while 'adverse drug reaction' (ADR) is used only with drugs. Both will be measured in the study. All subjects will be asked if they have experienced any untoward effects from the intervention. In the event that any adverse events and adverse effects will be noted, immediate medical attention will be given to the participant(s) and the expenses of which, will be shouldered by the investigators.	12 weeks	Yes