0.005% Sodium Hypochlorite Final Rinse Solution in Atopic Dermatitis

• ClinicalTrials.gov Identifier: NCT02241174
• Recruitment Status: Withdrawn
• First Posted: September 16, 2014
• Last Update Posted: October 20, 2015
• Sponsor: Makati Medical Center
• Information provided by (Responsible Party): Jamaine Cruz, MD, Makati Medical Center

Study Description

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..

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Sodium Hypochlorite	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: July 2014
• Estimated Primary Completion Date: December 2014
• Estimated Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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
Placebo Comparator: Placebo; 100ml distilled water will be used as a placebo and will be stored on amber bottles identical with the treatment group	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

Outcome Measures

Primary Outcome Measures :

1. Culture and sensitivity findings [ Time Frame: 12 weeks ]
   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.
2. Eczema Assessment Severity Index (EASI) [ Time Frame: 12 weeks ]

   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:

   1. Head/Neck
   2. Upper extremities
   3. Trunk
   4. Lower extremities

   In each of the body areas, the following key signs will be assessed:

   1. Erythema (E)
   2. Induration (I)
   3. Excoriation (Ex)
   4. Lichenification (L)

   Scoring from the above features:

   1. 0 - none
   2. 1 - mild
   3. 2 - moderate
   4. 3 - severe

   Body Surface Area involvement score:

   1. 0 = no eruption
   2. 1 = <10%
   3. 2 = 10%-29%
   4. 3 = 30% - 49%
   5. 4 = 50% - 69%
   6. 5 = 70% - 89%
   7. 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

3. Physician Global Assessment (PGA) Scale [ Time Frame: 12 weeks ]

   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%

Secondary Outcome Measures :

1. Adverse Effect [ Time Frame: 12 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 8 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Philippines

Makati Medical Center

Makati, NCR, Philippines, 1229

Sponsors and Collaborators

Makati Medical Center

Investigators

• Principal Investigator: Donna Marie L. Sarrosa, MD, FPDS; Makati Medical Center
• Principal Investigator: Jamaine Melisse L Cruz, MD; Makati Medical Center

More Information

• Responsible Party: Jamaine Cruz, MD, Dr., Makati Medical Center
• ClinicalTrials.gov Identifier: NCT02241174
• Other Study ID Numbers: SodiumHypochloriteAD
• First Posted: September 16, 2014
• Last Update Posted: October 20, 2015
• Last Verified: October 2015

Keywords provided by Jamaine Cruz, MD, Makati Medical Center:

Atopic Dermatitis

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Sodium Hypochlorite; Eusol; Disinfectants; Anti-Infective Agents