EUCTR2007-004635-29-ES进行中（未招募）不适用
Estudio aleatorizado, controlado con placebo, internacional, multicéntrico, doble ciego, de confirmación de dosis, para evaluar la seguridad y la eficacia de la crema ASF-1096 0,25%, 0,5% y 1% y placebo administradas dos veces al día en el tratamiento de las lesiones cutáneas del lupus eritematosoRandomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
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. Subjects of any gender aged from 18 to 85 years.
- •2. A clinical diagnosis of DLE or SCLE or SLE with chronic CLE lesions defined as:
- •A clinically confirmed diagnosis of DLE with sharply demarcated, erythematokeratotic, atrophic or scarring lesions.
- •A clinically confirmed diagnosis of SCLE with erythematosus macules, scaly
- •papulosquamous or annular/polycyclic type.
- •3. One to 5 lesions scoring at least moderate disease” on the IGA scale.
- •4. The physical examination without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study.
- •5. Sexually active females of childbearing potential should either be clinically sterile
- •(post-menopausal, undergone hysterectomy or tubal ligation), or should use a
- •medically accepted contraceptive regimen for at least 12 weeks prior to the study,
- •during the study and 1 month after the end of the study.
- •NOTE: For subjects in Germany and Denmark, all females of childbearing potential
- •should either be clinically sterile (post menopausal, undergone hysterectomy or tubal
- •ligation), or should use a medically accepted contraceptive regimen for at least 12 weeks prior to the study, during the study and 1 month after the end of the study. Medically accepted contraceptive regimens in these countries are specified as:
- •systemic contraceptive (oral, implant, injection).
- •diaphragm or cervical cap with intravaginal spermicide.
- •intrauterine device.
- •condom with intravaginal spermicide.
- •6. Willing and able to comply with the study procedures.
- •7. Prepared to grant authorised persons access to medical records.
- •8. Signed informed consent.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Active skin disease other than DLE or SCLE or SLE with chronic CLE lesions in the
- •tested areas, including acute CLE.
- •2. Concomitant, or within 4 weeks prior to dosing, treatment with local corticosteroids, immune modulators, or any other topical lupus erythematosus products.
- •3. Unstable use of systemic products for their lupus erythematosus.
- •4. Concomitant treatment with drugs with a known photosensitising potential e.g.
- •tetracyclines, griseofulvin, sulfonamides, thiazides, furosemide and tolbutamide.
- •5. Concomitant, or within 4 weeks prior to dosing, treatment with medicinal products
- •containing salbutamol.
- •6. Previous participation in an ASF-1096 study.
- •7. Symptoms of a clinically significant illness or behaviour that may influence the
- •outcome of the study in the 4 weeks before the study and during the study.
- •8. Participation in another clinical study, including the 4-week period preceding the
- •9. Known allergic reactions to components of the study preparations.
- •10. Pregnancy (according to pregnancy test) or nursing.
- •11. Other factors which may affect participation such as mental or legal incapacitation, drug or alcohol abuse within the last 2 years, or in the investigator’s opinion, subjects who may not be capable of following the study schedule for any reason.
研究者
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