0.005% Sodium Hypochlorite Final Rinse Solution in Atopic Dermatitis

NCT02241174 | Withdrawn Phase 1

• 1 other identifier: SodiumHypochloriteAD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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..

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (3)

• 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

• 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: 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

  12 weeks

• 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

Secondary Outcomes (1)

• Adverse Effect

  12 weeks

Study Arms (2)

Sodium Hypochlorite

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Sodium Hypochlorite

Interventions

Sodium Hypochlorite 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; Sodium Hypochlorite

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females more than 8 years old.
• Subjects with clinical diagnosis of atopic dermatitis (based on Hannifin and Rajka criteria).
• Healthy subjects with no other skin disease.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Makati Medical Center: lead

Study Sites (1)

Makati Medical Center

Makati, NCR, 1229, Philippines

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• Donna Marie L. Sarrosa, MD, FPDS

  Makati Medical Center

  PRINCIPAL INVESTIGATOR

• Jamaine Melisse L Cruz, MD

  Makati Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 16, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

PH (1)