Clinical Study Protocol Number DBI-201- Open Label, Single-dose, Dose Escalating Evaluation of the Safety and Tolerability of DBI-001 in Patients With Tinea Pedis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety Evaluation Cohort 1
研究概览
简要总结
This is an open-label, single-dose, dose escalating evaluation of the safety and tolerability of three dose levels of DBI-001 in patients with Tinea pedis. The purpose of the current protocol is to establish the safety and tolerability of a single application of J. lividum to the feet of patients with proven T. pedis. In addition, the effect of J. lividum on the T. pedis will also be evaluated.
详细描述
Open-label, single-dose, dose escalating evaluation of the safety and tolerability of three dose levels of DBI-001 in patients with Tinea pedis. The test product will be applied by study personnel at the investigational site. Each subject will have a single application of approximately 0.5 ml of the test article applied to each foot. Both affected and unaffected feet will be treated covering the web spaces, toes, toe nails as well as the plantar and lateral aspect of both feet. Each of the three groups will have 4 subjects. After the first cohort has completed their day 7 visits, if no significant tolerability or safety issues identified the second cohort will be enrolled. After the second cohort has completed the day 7 visits and if no significant tolerability of safety issues is identified the third cohort will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects with the following will be excluded from this study:
- •Any dermatological conditions that could interfere with clinical evaluations.
- •Any underlying disease(s) or some other dermatological condition that requires the use of interfering topical or systemic therapy.
- •Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications applied to the foot: Topical astringents and abrasives (e.g. Burrow's solution) 1 week Topical antibiotics and antifungal on the infected area (e.g. Neomycin, Miconazole, Clotrimazole, Terbinafine) 2 weeks Anti-inflammatories, corticosteroids, topical immunomodulators (e.g. Pimecrolimus, Tacrolimus) 4 weeks
- •Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications: Corticosteroids (including intramuscular injections) (e.g. Triamcinolone acetonide) 4 weeks Antibiotics (e.g. Tetracycline, Cephalosporins, etc.) and/or Antifungal agents (e.g. Fluconazole, Itraconazole, Terbinafine, etc.) 4 weeks Systemic immunomodulators (e.g. Cyclophosphamide, Azathioprine, Biologicals-Monoclonal Antibodies. 4 weeks
- •Treatment of any type of cancer within the last 6 months.
- •History of any significant internal disease (which contraindicates use of live microbiome e.g. leukemia, liver failure, cardiovascular disease)
- •Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
- •AIDS or AIDS related complex by medical history.
- •Known or suspected immune suppressive medications or diseases.
- •Diabetes mellitus Type I or II by medical history.
- •Peripheral vascular disease based on medical history.
- •Any subject not able to meet the study attendance requirements.
- •Subjects who have participated in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.
研究组 & 干预措施
Cohort 1
Cohort 1 DBI-001 Gel with 10^6 CFUs/ml of J.lividum
干预措施: Janthinobacterium lividum (Drug)
Cohort 2
Cohort 2 DBI-001 Gel with 10^7 CFUs/ml of J.lividum
干预措施: Janthinobacterium lividum (Drug)
Cohort 3
Cohort 3 DBI-001 Gel with 10^8 CFUs/ml of J.lividum
干预措施: Janthinobacterium lividum (Drug)
结局指标
主要结局
Safety Evaluation Cohort 1
时间窗: 28 days
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe
Safety Evaluation Cohort 2
时间窗: 28 days
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe
Safety Evaluation Cohort 3
时间窗: 28 days
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe
次要结局
未报告次要终点