EUCTR2017-003105-18-NL进行中（未招募）1 期
A randomized, placebo-controlled, evaluator-blinded, study to assess the anti-inflammatory effects of topical erythromycin and clindamycin in patients with inflammatory facial acne
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Healthy male and female subjects, 18 to 45 years of age. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AV following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
- •2.Mild to moderate inflammatory acne vulgaris on the face, =5 inflammatory lesions (papules and/or pustules), present at screening and baseline visit
- •3.A maximum of 5 nodules present at screening and baseline visit
- •4.Inflammatory acne present for at least 6 months
- •5.Fitzpatrick skin type I-II (Caucasian)
- •6.Able and willing to give written informed consent and to comply with the study restrictions.
- •7.Willing to comply with 2x2mm facial skin punch biopsies
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Severe acne where systemic treatment is needed
- •2.Use of any topical (anti-acne) medication (prescription or OTC) within 2 weeks prior to baseline
- •3.Use of any oral/systemic treatment for acne, including oral antibiotics, excluding OAC, within 4 weeks prior to baseline
- •4.Use of systemic isotretinoin within 6 months prior to baseline
- •5.History of pathological scar formation (keloid, hypertrophic scar)
- •6.Known hypersensitivity to erythromycin or clindamycin, drugs of the same class, or any of their excipients.
- •7.Known contact dermatitis reaction to any product
- •8.Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.
- •9.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
- •10.Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening
- •11.Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding
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