EUCTR2005-001474-27-DK进行中（未招募）不适用
A randomised, double-blinded parallel group study to compare efficacy and tolerability of topically applied Baceca and Tazarotene against placebo and Tazarotene in patients with basal cell carcinoma - N/A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Main Criteria for Inclusion:
- •1. men and women aged 18 years and older
- •2. informed consent signed by the patient
- •Patients with at least one BCC tumor can be included if the lesion meets the following criteria:
- •3. macroscopically (clinically) consistent with BCC
- •4. histologically confirmed diagnosis of BCC for the tumor lesion to be treated.
- •5. The tumor has to be at least 0,5 cm2, but not more than 4cm2.
- •6. exhibits clearly defined margins
- •7. easily identifiable and treatable
- •8. located anywhere on the body except on eye lids, lips, nose, mucosa or in
- •anogenital region
- •9. A tumor biopsy within the last 6 months is usable according to protocol. The BCC
- •must not have been treated with a drug or a non-drug treatment which could
- •have a direct influence on the tumor.
- •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. females of child bearing potential
- •2. presence or history of disorders commonly accepted as contraindications for the
- •treatment with 2-PPA like jaundice or any serious hepatic, pancreatic, renal or
- •haematologic function disorders or any significant cardiovascular, haematologic,
- •neurologic, malignant, psychiatric, respiratory, metabolic or hypertensive disease.
- •3. presence of disorders commonly accepted as contraindications for topical retinoid
- •treatment like inflammation of the skin following perioral dermatitis, acute eczema,
- •4. patients with a known allergy or history of hypersensitivity to any of the
- •substances in the study medication
- •5. patients with other skin disorders that might interfere with BCC evaluation.
- •6. any concomitant BCC treatment or any BCC treatment within the last 30 days
- •including any topical treatment , photodynamic therapy or radiation or
- •systemic therapy or any treatment to any BCC lesion (different to target lesion)
- •that may influence the course of BCC.
- •7. any concomitant therapy like curettage, electrodesiccation, cryotherapy or surgical
- •excision of the BCC lesion.
- •8. any orally administered concomitant treatment or any treatment within the last 30
- •days with drugs like corticosteroids (except a low dose steroid treatment below
- •20mg/day, if the treatment is constant before, during and after the study), retinoids,
- •COX inhibitors, immunomodulators or immunsuppressiva, any experimental drug or
- •with systemic chemotherapeutics within the last 6 months
- •9. recent history of alcohol abuse or any other substance abuse
- •10. patients unable to comply with the study protocol
研究者
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