NCT01808950终止1 期
Bi-center, Open Label, Non-comparative Trial Exploring Efficacy and Safety of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma (nBCC)
Spirig Pharma Ltd.2 个研究点 分布在 2 个国家目标入组 4 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Histological Cure Rate
研究概览
简要总结
The primary objective is the observation and description of the preliminary efficacy of resiquimod gel 0.06% on a single nodular basal cell carcinoma (nBCC) in a small group of patients.
详细描述
efficacy assessments:
- Histopathological findings based on the biopsies of the primary tumor location and the tissue excision at the end of trial (histological cure).
- Description of the clinical-therapeutic effect of resiquimod on nBCC (nodular-basal cell carcinoma) by visual inspection (clinical evaluation of treatment area and assessment of complete clinical clearance)
- RNA-analysis (analysis of gene expressions for cytokines, cytotoxic and apoptotic signals)
- Investigator's global judgment of efficacy by means of a 7-point scale
Safety assessments:
- Evaluation of Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Evaluation of local tolerability (local skin reactions as erythema, edema, erosion/ulceration, exsudate, dryness, encrustation) by means of symptom scoring scales (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe).
- Evaluation of systemic tolerability [hematology (erythrocytes, leucocytes including neutrophils, hemoglobin, hematocrit, thrombocytes), blood chemistry (alkaline phosphatase, bilirubin, aspartate transaminase (ASAT), alanine transaminase (ALAT), serum creatinine), vital signs]. The thresholds concerning laboratory abnormalities that determine patient's discontinuation from trial were predefined upfront.
- Evaluation of the number of patients withdrawn from the trial
- Investigator's global judgment of tolerability by means of a 6-point scale
- Photographic documentation of the treatment area
Exploratory parameter:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent form.
- •Male or non-pregnant, non-lactating female, ≥ 18 years.
- •Must have a previously untreated, histologically confirmed nBCC on head, neck, trunk or arms.
- •nBCC must not be larger than 20 mm in diameter and must be less than 5 mm in depth.
- •Willing and able to participate in the trial as an outpatient and comply with all trial requirements.
排除标准
- •nBCC located close to or at mouth or eyes.
- •Patients who have had an organ transplant.
- •Known autoimmune disorder (especially psoriasis), impaired immune system (e.g. HIV), known thyroid abnormalities, known depression.
- •An open wound or an infection in treatment area.
- •Dermatological disease or condition (e.g. rosacea, atopic dermatitis, eczema) in the treatment or surrounding area that might impair trial assessments.
- •Evidence of an active infection or systemic cancer.
- •Flu or flu-like symptoms (including general indisposition, fever, nausea, muscle pain, chills) within a week before start of the trial.
- •Known allergy or hypersensitivity to any of the trial gel ingredients.
- •Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., renal or hepatic disease).
- •Current alcohol abuse or chemical dependency as assessed by the investigator.
- •Patient who is detained or committed to an institution by a law court or by legal authorities.
- •Participation in another clinical trial within one month before start of the trial.
研究组 & 干预措施
0.06% Resiquimod Gel - A
Experimental
- 60 mg gel
- Once daily prior to normal sleeping hours
- 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
干预措施: 0.06% Resiquimod Gel - A (Drug)
0.06% Resiquimod Gel - B
Experimental
- 100 mg gel
- Once daily prior to normal sleeping hours
- 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
干预措施: 0.06% Resiquimod Gel - B (Drug)
0.06% Resiquimod Gel - C
Experimental
- 100 mg gel
- Once daily prior to normal sleeping hours
- 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
- The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed
干预措施: 0.06% Resiquimod Gel - C (Drug)
结局指标
主要结局
Histological Cure Rate
时间窗: 8 weeks after a maximal treatment period of 4 weeks
次要结局
- Global Judgment of Tolerability by Investigator by Means of a 6-point Scale(8 weeks after a maximal treatment period of 4 weeks)
- Evaluation of Local Tolerability by Means of 5-point Scales(up to 12 weeks)
- Complete Clinical Clearance Rate(8 weeks after the 4 weeks treatment period)
- Evaluation of Systemic Tolerability Based on Haematology and Blood Chemistry Values and Vital Signs(up to 12 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
3 期
Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSDNMOSDNeuromyelitis Optica Spectrum DisordersNCT06724809Alexion Pharmaceuticals, Inc.21
尚未招募
1 期
A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT05172856Innovent Biologics (Suzhou) Co. Ltd.110
已完成
2 期
Safety and Efficacy of the Combination of Tirabrutinib and Entospletinib With and Without Obinutuzumab in Adults With Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic LeukemiaNCT02983617Gilead Sciences36
已完成
2 期
Study to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib and Idelalisib With and Without Obinutuzumab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic LeukemiaNCT02968563Gilead Sciences35
已完成
2 期
PRO 140 in Treatment-Experienced HIV-1 SubjectsHIV-1-infectionNCT03902522CytoDyn, Inc.6