ISRCTN33393967已完成1 期
A phase I/II randomized, assessor-blind, vehicle-controlled study to assess the safety, tolerability, and pharmacodynamics of DLQ03 in a wound healing model in patients with mild to moderate atopic dermatitis that are colonized with S. Aureus.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
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
- 性别
- All
入选标准
- •1. Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 65 years of age, inclusive. The health status is verified by absence of evidence of any clinically significant active or uncontrolled chronic disease other than AD that potentially may influence the adherence to the study and/or assessments in the study, following a detailed medical history and a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology, and urinalysis.
- •2. Diagnosed with AD according to the Hannifin criteria (Hannifin 1980).
- •3. Suitable target lesion defined as an eczema lesion of at least 0.5% BSA (excluding the face) at screening and baseline day 1 for part A and 2 suitable target lesions defined as two eczema lesions of at least 0.5% BSA (excluding the face) at screening and baseline day 1 for part B. In Part B the location of one of the lesions must be such that suction blisters can be drawn on the lesion.
- •4. Target lesion is cultured positive for S. aureus on two consecutive occasions during the screening period:
- •5. Maximum 15% body surface area (BSA) affected at screening and baseline (day 1).
- •6. Willing to refrain from washing the target lesion(s) at least 6 but preferably 12 hours before every study visit.
- •7. Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.
- •8. Able to participate and willing to give written informed consent and to comply with the study restrictions.
- •9. Has the ability to communicate well with the Investigator in the Dutch language.
排除标准
- •1. Any current and/or recurrent clinically significant skin condition which will interfere with the clinical findings of the study as assessed by the investigator.
- •2. Ongoing use of prohibited atopic dermatitis treatments. Washout periods prior to baseline (first dose of the study drug) are as follows:
- •2.1. Target lesions only: Any topical medication (prescription or over-the-counter [OTC]) for 14 days)
- •2.2. Cyclosporine/oral steroids/azathioprine/mycophenolate mofetil/other systemic AD treatments: 4 weeks
- •2.3. Phototherapy: 3 weeks
- •2.4. Biologics: 5 half-lives of the drug
- •2.5. Systemic antibiotics: 14 days
- •3. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment and/or not willing to refrain from these during the study.
- •4. Part B only: Subject has a Fitzpatrick’s Skin Phototype = 4.
- •5. Begin treatment with systemic or locally acting medications which might counter or influence the study aim (e.g., medications which are known to provoke or aggravate atopic dermatitis).
- •6. Known hypersensitivity to the F6H8 eyedrop.
- •7. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding.
- •8. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
- •9. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
- •10. A positive drug and/or alcohol test at screening (rescreening is allowed).
- •11. Have positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) results.
- •12. Any disease associated with immune system impairment, including auto-immune diseases, HIV, and transplantation patients.
- •13. Any disease associated with thyroid dysfunction or impaired renal function.
- •14. Have history of malignancy, except adequately treated non-invasive skin cancer (basal or squamous cell carcinoma).
- •15. History of pathological scar formation (keloid, hypertrophic scars)
- •16. Any form of body modification hindering study assessments (e.g., tattoos, piercings, implants)
- •17. Have clinically significant illness or infection that may, in the opinion of the investigator, contraindicate participation in the trial or interfere with the outcome of the trial in the 4 weeks before the baseline visit and during the trial.
- •18. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the study
- •19. Have used Evotears®, Evotears® Omega, Novatears® or Novatears® Omega one week before Day 1 or plan to use it during the course of the trial
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