A One Month, Randomized, Two-center, Parallel-group, Double-blind,Placebo-controlled Study to Evaluate the Efficacy and Safety of FiteBac Hand Sanitizer TID vs Emollient Therapy in the Management of Hand Dermatitis in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Efficacy of fiteBac compared to emollient therapy
研究概览
简要总结
Hand dermatitis, (a rash, or eczema, on the hands) is a common skin condition that affects approximately 10% of the population. It can be caused by a wide variety of things, such as allergens or irritants. For some, it can be painful and disfiguring. In moderate to severe cases, hand dermatitis can interfere greatly in the quality of life of the affected person, interfering with work and social functions. This can have a negative psychological effect as well.
FiteBac Skin Care Gel is a new over-the-counter hand sanitizer that has been used for hospital and dental hand infection control. This product contains a germicide, to prevent infection. It also contains a silicone polymer. This makes the hand gel more durable, causing it to remain on the skin longer. Despite this durability, the hand gel still allows the skin to naturally perspire (sweat).
As people in the health-care industry have used this new product with the goal of reducing hand infections, it has been noted that FiteBac Skin Care Gel also seems to have reduced hand dermatitis and improved personal skin condition. The purpose of this study is to scientifically measure skin improvement in a population of study subjects with hand dermatitis.
详细描述
- Informed consent must be signed and understood by subject.
- Symptoms and history consistent with hand dermatitis based on symptoms and clinical history (as described in refs 4-7).
- Males or females, 18-70 years of age, in generally good health with no significant underlying systemic disease requiring ongoing medications.
- Hand eczema severity index (HECSI) with a score of greater than 50 (see Table 1 and reference 5)
- Physician global assessment (PGA) of moderate to severe (with PGA severity scores graded as in Table 1 of reference 8: severe, moderate, mild, almost clear, clear).
3.2.3. Exclusion criteria
- Topical corticosteroid or calcineurin inhibitor treatment during the last 7 days, prior to enrollment, on the hands and forearms
- Systemic treatment with corticosteroids or other immunosuppressives during the last 14 days.
- Subjects currently receiving (or received during the previous 4 weeks) other investigational drugs, treatments or devices, or participating in another clinical study.
- Treatment with ultraviolet (UV) light (including tanning) during the previous 4 weeks.
- Acute dermatitis outbreak on the arms or hands.
- Subjects unable to comply with protocol restrictions
- Subjects known to be unreliable or non-compliant with medical treatment, or unwilling to comply with multiple return visits.
- Any condition or prior/present treatment, in the opinion of the investigators, should render the patient ineligible for the study
- Known allergy to benzalkonium chloride or other ingredients in the fiteBac vehicle
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, 18-70 years of age, in generally good health with no significant underlying systemic disease requiring ongoing medications.
- •Hand eczema severity index (HECSI) with a score of greater than 50 (see Table 1 and reference 5)
- •Physician global assessment (PGA) of moderate to severe (with PGA severity scores graded as in Table 1 of reference 8: severe, moderate, mild, almost clear, clear).
排除标准
- •Topical corticosteroid or calcineurin inhibitor treatment during the last 7 days, prior to enrollment, on the hands and forearms
- •Systemic treatment with corticosteroids or other immunosuppressives during the last 14 days.
- •Subjects currently receiving (or received during the previous 4 weeks) other investigational drugs, treatments or devices, or participating in another clinical study.
- •Treatment with ultraviolet (UV) light (including tanning) during the previous 4 weeks.
- •Acute dermatitis outbreak on the arms or hands.
- •Subjects unable to comply with protocol restrictions
- •Subjects known to be unreliable or non-compliant with medical treatment, or unwilling to comply with multiple return visits.
- •Any condition or prior/present treatment, in the opinion of the investigators, should render the patient ineligible for the study
- •Known allergy to benzalkonium chloride or other ingredients in the fiteBac vehicle
结局指标
主要结局
Efficacy of fiteBac compared to emollient therapy
时间窗: 1 month
- To compare the efficacy of fiteBac skin care versus emollient therapy using standardized questionnaires, physical findings and photography over a one month treatment period in adults with hand dermatitis.
次要结局
- Adverse events(1 month)
- Bacterial counts(1 month)
- Physician Global Assessment(1 month)
- Number of flares(1 month)
- Number of study discontinuations(1 month)
- Patients Global Assessment score(1 month)
研究者
Donald Leung, MD, PhD
Principal Investigator
National Jewish Health