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0.005% Sodium Hypochlorite Final Rinse Solution in Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02241174
Recruitment Status : Withdrawn (study materials have expired, no patients were enrolled)
First Posted : September 16, 2014
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Jamaine Cruz, MD, Makati Medical Center

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241174


Locations
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Philippines
Makati Medical Center
Makati, NCR, Philippines, 1229
Sponsors and Collaborators
Makati Medical Center
Investigators
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Principal Investigator: Donna Marie L. Sarrosa, MD, FPDS Makati Medical Center
Principal Investigator: Jamaine Melisse L Cruz, MD Makati Medical Center

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Responsible Party: Jamaine Cruz, MD, Dr., Makati Medical Center
ClinicalTrials.gov Identifier: NCT02241174     History of Changes
Other Study ID Numbers: SodiumHypochloriteAD
First Posted: September 16, 2014    Key Record Dates
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:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Sodium Hypochlorite
Eusol
Disinfectants
Anti-Infective Agents