Overview
0.005% Sodium Hypochlorite Final Rinse Solution in Atopic Dermatitis
Status:
Withdrawn
Withdrawn
Trial end date:
2015-02-01
2015-02-01
Target enrollment:
0
0
Participant gender:
All
All
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..Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Makati Medical CenterTreatments:
Eusol
Pharmaceutical Solutions
Sodium Hypochlorite
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.