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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 November 2015 |
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Main ID: |
NCT02241174 |
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Date of registration:
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12/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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0.005% Sodium Hypochlorite Final Rinse Solution in Atopic Dermatitis
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Scientific title:
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Efficacy of 0.005% Sodium Hypochlorite Final Rinse Solution on the Reduction of Staphylococcus Aureus Colonization in Atopic Dermatitis: A Randomized Controlled Trial |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02241174 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Philippines
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Contacts
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Name:
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Donna Marie L. Sarrosa, MD, FPDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Makati Medical Center |
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Name:
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Jamaine Melisse L Cruz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Makati Medical Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
8 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atopic Dermatitis
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Intervention(s)
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Drug: Sodium Hypochlorite
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Primary Outcome(s)
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Physician Global Assessment (PGA) Scale
[Time Frame: 12 weeks]
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Culture and sensitivity findings
[Time Frame: 12 weeks]
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Eczema Assessment Severity Index (EASI)
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Adverse Effect
[Time Frame: 12 weeks]
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Secondary ID(s)
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SodiumHypochloriteAD
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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