Efficacy and Tolerability of MetaDerm in Subjects withModerate to Severe Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The primary endpoint is: Change in Scoring of Atopic Dermatitis (SCORAD) score.
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 currenttherapy of AD is reactive, where the flares are treated through symptomaticmanagement with topical corticosteroids and calcineurin inhibitors. Given thatthese medications have long-term side-effects, and given the chronicallyrelapsing immunopathogenic nature of AD, there is an imperative need for saferanti-inflammatory medications. Haus Bioceuticals has developed a topicaltreatment for eczema/atopic dermatitis (AD) denoted MetaDerm, and havedemonstrated that MetaDerm is safe and profoundly effective in the treatment ofAD, controlling signs and symptoms in 85% of patients with AD. MetaDerm was characterized to have unique immunosuppressive profiles identified to be TLR, MAPK and NFkB- modulated, implying distinct anti-inflammatory and immunomodulatory modes of action. Safety study demonstrated that MetaDerm was characterized as non-toxic and non-irritant as per OECD guidelines, and did not demonstrate any cytotoxicity to various non-inflammatory cells tested, including fibroblast and epithelial cells. MetaDerm has the potential to have significant therapeutic and clinical impact and address a significant unmet need for a safe and effective topical therapy in patients with AD.
Total Duration : 17 weeks
Wash out : 01 Week
Treatment period: 12 weeks
Recurrence : 4 weeks
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
- •â€¢Moderate to severe atopic dermatitis as determined by Physician’s Global Assessment (PGA >
- •â€¢Males and females, age
- •65 years old inclusive.
排除标准
- •â€¢Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 2 weeks.
- •â€¢Currently or has been diagnosed or treated for cancer in the past 5 years.
- •â€¢Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies).
- •â€¢Has a known hypersensitivity to any corticosteroid creams.
- •â€¢Has any active infections or has used antibiotics in the past 7 days.
- •â€¢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.
- •â€¢Has used any immunosuppressant drugs or immunotherapy within the past 30 days or 5 half-lives.
- •â€¢Is an employee of the sponsor company or clinical testing site.
- •â€¢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.
- •â€¢Is currently pregnant or lactating or planning to become pregnant in the next 6 months (using double contraception for prevention).
- •â€¢Has a history of keloid formation following skin injury.
- •â€¢Is routinely taking anti-coagulant medications (i.e. Plavix,Coumadin, warfarin, heparin, etc.) •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
The primary endpoint is: Change in Scoring of Atopic Dermatitis (SCORAD) score.
时间窗: [Time Frame: Baseline to week 12]
次要结局
- Absolute change in Eczema Area and Severity Index (EASI) score.(Proportion of patients achieving a Physician’s Global Assessment)