CTRI/2019/12/022212尚未招募2 期
A Multi-center, Randomized, Double-Blind, Parallel-group, Vehicle-Controlled Study to Evaluate the Safety, Efficacy and Pharmacokinetics of DFD-25 (Zileuton Ointment), 1.25% and 5%, in Subjects with Moderate to Severe Atopic Dermatitis (AD) Over a 4 Week Treatment Period
Dr Srinivas Sidgiddi MD Director Clinical Development0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subject understands the study procedures, is willing to comply with the study procedures and required visits and agrees to participate by giving written informed consent. Subjects with a legal guardian, must have the written informed consent of the legal guardian
- •2. Subject (or legal guardian) must be willing to authorize use and disclosure of protected health information collected for the study
- •3. Male and female subjects aged 18 years to 75 years
- •4.Subjects must be diagnosed with Atopic Dermatitis (AD) as per revised Hanifin and Rajka criteria
- •5. Subjects must have IGA grade of â??Moderate (3)â?? to â??Severe (4)â?? at Baseline
- •6. Subjects must have AD lesions affecting <=20% of the body surface area (BSA) at Baseline (subjects will be instructed to avoid applying IP around eyes, mouth and nostrils).
- •7. Willing to provide skin biopsy of the target lesion at Baseline and end of treatment visits
- •8. Female subjects of childbearing potential in addition to having a negative urine pregnancy test, must agree to the use of a reliable method of contraception (e.g., total abstinence, IUD, a double-barrier method [such as condom plus diaphragm with spermicide], oral, transdermal, injected or implanted non- or hormonal contraceptive),
- •9. throughout the study. If the female is using a hormonal contraceptive, the same product must be taken for 3 months prior to study treatment and must agree not to replace with some other hormonal contraceptives during the study.
- •A female is considered of childbearing potential unless she is:
- •i. pre-menarche
- •ii. postmenopausal for at least 12 months prior to IP administration
- •iii.without a uterus and/or both ovaries; or has been surgically sterile (i.e., tubal ligation) for at least 6 months prior to IP administration
- •10. Subjects must be able to have >= 28 days washout from the following prohibited medications:
- •i. Oral or Intravenous corticosteroids (nasal and inhaled steroids are allowable)
- •ii. Any biological therapy (including intravenous immunoglobulins)
- •iii. UVA/UVB therapy
- •iv. PUVA (psoralen plus ultraviolet A) therapy
- •v. Systemic cytotoxic or immunosuppressive drugs (e.g. Methotrexate, Azathioprine, Cyclosporine etc.)
- •vi. Topical and Systemic Immunomodulators (e.g. Tacrolimus, Sirolimus, Pimecrolimus, Mycophenolate mofetil, Imiquimod etc.)
- •vii. Systemic, topical or intralesional interferon
- •11. Subjects must be able to have >= 14 days washout from the following prohibited medications:
- •i. Systemic antibiotics and anti-fungals
- •ii. Calcipotriene or other vitamin D preparations
- •iii. Retinoids (oral and topical)
- •iv. Topical corticosteroids (for skin)
- •12. Subjects must be able to have >= 7 days washout from the following prohibited medications:
- •i. Topical or systemic antihistamines
- •ii. Systemic leukotriene inhibitors (montelukast)
- •iii.Topical or systemic NSAID (however daily low-dose aspirin is allowed, as long as the subject has been on a stable dose, <= 100 mg once a day, for 60 days prior to the start of the study; subjects may use acetaminophen/paracetamol as required)
- •iv. Topical antibiotics
- •v. Other topical drug products
- •13. Subjects must agree not to use any product on the treatment area during the entire course of study except the products advised by the Investiga
排除标准
- •1. Known or suspected hypersensitivity to zileuton or any component of the formulation of the study medication
- •2. Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline, which would interfere with evaluations
- •3. History or presence of other skin conditions, e.g., scabies, psoriasis, rosacea, erythroderma, ichthyosis that may either confound the diagnosis of AD or interfere with the assessment of study endpoints
- •4. History or presence of Nethertonâ??s Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection
- •5. Clinical evidence of severe, uncontrolled autoimmune, cardiovascular, gastrointestinal, hematological, hepatic, neurologic, pulmonary or renal disease
- •6. Serum ALT and/or AST >= 3 times ULN at screening
- •7. Significant history (within the past year) of alcohol or drug abuse
- •8. Unstable AD or any consistent requirement for high potency topical corticosteroids as judged by the Investigator
- •9. Current use of biologic therapy
- •10. Participation in any clinical research study within 30 days of the Baseline Visit
- •11. Concomitant use of cosmetics or other topical drug products on or near the selected treatment area, except the products advised by the Investigator
- •12.Anticipated concurrent requirement for treatment with propranolol, warfarin and theophylline
- •13.Cosmetic or therapeutic procedures (e.g. laser, peeling, photodynamic therapy) within 4 weeks and within 2 cm of the selected treatment area
- •14. Any systemic cancer therapy or diagnosis within 6 months of the Baseline Visit
- •15. Females who are pregnant or lactating or planning to become pregnant during the study period
- •Subjects who are unable to comply with the study requirements for any reason
研究者
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