NL-OMON44210已完成不适用
A single-arm, observational study to explore and characterize wound healing after skin punch biopsies in healthy volunteers - Wound healing in healthy volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Eligible subjects must meet all of the following inclusion criteria at screening:
- •1. Healthy subjects, 18 to 30 years of age (inclusive). The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease following a detailed medical history, a complete physical examination including vital signs, blood sampling of hematology, chemistry, and virology, urinalysis, urine drug and cotinine testing, and alcohol breath testing. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
- •2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive
- •3. Fitzpatrick Skin type I-II (Caucasian type).
- •4. Eligible lower back to perform biopsies (no excessive hair growth, no local skin disorder)
- •5. Willing to give written informed consent and willing and able to comply with the study protocol.
排除标准
- •Eligible subjects must meet none of the following exclusion criteria at screening:
- •1. History of pathological scar formation (keloid, hypertrophic scars)
- •2. Any form of body modification of the lower back hindering biopsy collection of unaltered skin (e.g. tattoos, piercings, implants)
- •3. Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients.
- •4. Requirement of immunosuppressive or immunomodulatory medication, including glucocorticoids, non-steroid anti-inflammatory drugs (NSAIDs), and chemotherapeutic drugs within 30 days prior to enrollment or planned to use during the course of the study.
- •5. Have any current and / or recurrent pathologically, clinical significant relevant skin condition.
- •6. Use of topical medication (prescription or over-the-counter (OTC)) within 30 days of the start of the study in local treatment area.
- •7. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding.
- •8. Current smoker and/or regular user of other nicotine-containing products (e.g., patches).
- •9. Average consumption of more than 14 units of alcohol per week
- •10. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment or planned to do so during the course of the study
- •11. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
- •12. Loss or donation of blood over 500 mL within three months prior to screening.
- •13. Any (medical) condition that would, in the opinion of the investigator, potentially compromise the safety or compliance of the subject or may preclude the subjects* successful completion of the clinical trial.
研究者
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