Efficacy of 0.005% Sodium Hypochlorite Final Rinse Solution on the Reduction of Staphylococcus Aureus Colonization in Atopic Dermatitis: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Physician Global Assessment (PGA) Scale
研究概览
简要总结
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..
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Sodium Hypochlorite (Drug)
Placebo
100ml distilled water will be used as a placebo and will be stored on amber bottles identical with the treatment group
干预措施: Sodium Hypochlorite (Drug)
结局指标
主要结局
Physician Global Assessment (PGA) Scale
时间窗: 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%
Eczema Assessment Severity Index (EASI)
时间窗: 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
Culture and sensitivity findings
时间窗: 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.
次要结局
- Adverse Effect(12 weeks)
研究者
Jamaine Cruz, MD
Dr.
Makati Medical Center