A Study to Evaluate the Efficacy and Safety of Metaderm M1 and Metaderm M5 Cream Formulas in Patients with Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Scoring of Atopic Dermatitis (SCORAD) score. [Time Frame: baseline to week 12]
研究概览
简要总结
Atopic dermatitis (AD) is a chronic inflammatoryskin disease characterized by a disturbance of epidermal-barrier function thatresults in intensely pruritic subacute and chronic eczematous plaques. As themost common cause of chronic inflammatory skin diseases, AD is a major cause ofmorbidity and suffering, affecting upto 30% of children, and increasing inprevalence throughout the world. The current therapy of AD is reactive, wherethe flares are treated through symptomatic management with topicalcorticosteroids and calcineurin inhibitors. Given that these medications havelong-term side-effects, and given the chronically relapsing immunopathogenicnature of AD, there is an imperative need for safer anti-inflammatorymedications. Haus Bioceuticals (Haus) has developed a topical treatment foreczema/atopic dermatitis (AD) denoted MetaDerm, and have demonstrated thatMetaDerm is safe and profoundly effective in the treatment of AD. This study isaimed to further evaluate the therapeutic potential of a new MetaDerm cream inAD.
Total Study Duration: 13 Weeksfor each subject
Wash out Period: 1 week
Treatment Period: 1 week
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Moderate to severe atopic dermatitis as determined by Physician’s Global Assessment (PGA > 3) and SCORAD > 25 (SCORAD and PGA will incorporate whole body assessments) 2)Males and females, age
- •65 years old inclusive.
排除标准
- •Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 3 months.
- •Currently or has been diagnosed/treated for cancer in the past 5 years.
- •Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or antihistamines for asthma or allergies).
- •Has a known hypersensitivity to any corticosteroid creams.
- •Has any active infections or has used antibiotics in the past 7 days.
- •Has any physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos, extensive scarring, excessive hair growth or acne) 7) Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results.
- •Has used any immunosuppressant drugs or immunotherapy within the past 30 days or 5 half-lives.
- •Is an employee of the sponsor company or clinical testing site.
- •Is dependent on oral medication for any skin disease/condition or could not, in the opinion of the Investigator tolerate the restriction of discontinuing the medicine as required in this study.
- •Is currently pregnant or lactating or planning to become pregnant in the next 6 months (using double contraception for prevention).
- •Any other condition or factor the Investigator or their duly assigned representative believes may affect the ability of the subject to complete the study or the interpretation of the results.
结局指标
主要结局
Change in Scoring of Atopic Dermatitis (SCORAD) score. [Time Frame: baseline to week 12]
时间窗: 12 Weeks for each subject
次要结局
- Proportion of patients achieving a Physician’s Global Assessment((PGA) score of 0 or 1 [Time Frame: baseline to week 12])