A Randomized, Double-Blinded, Aqueous Gel-Controlled Dose Escalating Trial to Study the Safety and Antimicrobial Efficacy of DBI-002 Probiotic vs. Aqueous Gel and Vehicle Gel vs. Aqueous Gel in Adults With Tinea Versicolor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor)
研究概览
简要总结
A Randomized, Double-Blinded, Aqueous Gel-Controlled Dose Escalating Trial to Study the Safety and Antimicrobial Efficacy of DBI-002 Probiotic vs. Aqueous Gel and Vehicle Gel vs. Aqueous Gel in Adults with Tinea Versicolor (DBI-202).
详细描述
All subjects are required to have a clinical diagnosis of Tinea Versicolor on their chest and back. Each subject will serve as their own control, with aqueous gel applied to the chest or back, and the non-aqueous gel (DBI-002 or vehicle) applied to the opposite side. Treatment kits will be assigned sequentially to subjects. The subject and the investigator will be blinded to the pre-defined randomization assignments.
In this Phase IIA proof-of-mechanism study, cohorts 1, 2, and 3 were designed to be similar to a dose-escalating study. These cohorts will be enrolled sequentially, with a safety pause in between cohorts to evaluate events and/or local tolerability to topical application of the investigational product (DBI-002) or aqueous gel. Within each cohort, the first two subjects enrolled will have a single application of DBI-002 and aqueous gel, with a pause to assess adverse events and local tolerability. In the absence of safety concerns, the remaining subjects in that cohort will be enrolled to receive five consecutive daily applications of DBI-002 and aqueous gel. Cohort 1 will be low dose. Cohort 2 will be medium dose. Cohort 3 will be high dose. In the absence of safety concerns, the Investigator will proceed to enroll the next cohort, or extend (EXT) the enrollment of a cohort upon receiving Ethics Committee approval. Single-dose subjects remain in their original single-dose cohort assignment and do not dose-escalate, nor participate in the multiple-dose portion of that cohort, nor Cohort 4.
The fourth cohort, Cohort 4, was designed to compare vehicle with aqueous gel. All subjects in this cohort will be required to receive five consecutive daily applications of vehicle and aqueous gel. The Investigator may enroll cohort 4 in parallel with the above cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand, agree to and sign the study Informed Consent Form (ICF). If the subject is unable to provide consent him/herself, the subject's legally acceptable representative may provide written consent.
- •Male or Female Subjects of any race 18 - 65 years of age.
- •Subjects with a clinical diagnosis of Tinea versicolor (TV is a common benign superficial cutaneous fungal infection usually characterized by hypopigmented or hyperpigmented macules and patches on the chest and back).
- •A positive potassium hydroxide (KOH) examination consistent with Malassezia prior to the treatment period done at the clinical site.
- •Agree to not use soap and water on the chest and back for at least 12 hours before the study visits for Baseline/Day 1, Day 5, and Day 14, and follow all study instructions for use of soap and water on the chest and back during participation in the study.
排除标准
- •Females who are pregnant, planning a pregnancy, or breastfeeding.
- •Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation.
- •Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below).
- •Known sensitivity to any of the components of the study medication.
- •Use of a prescription or non-prescription topical treatment on the targeted TV anatomical locations within the previous 4 weeks, for example: anti-fungal, antibacterial or anti-microbial products, selenium and anti-inflammatories (e.g., corticosteroids).
- •Use of a systemic anti-fungal or antibiotic treatment for TV within the previous 4 weeks, Use of medicated shampoos and/or soaps within the previous 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 investigational product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure (IB).
- •AIDS or AIDS related complex by medical history.
- •Known or suspected use of immunosuppressive medications and/or has a known or suspected autoimmune disease.
- •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
DBI-002 probiotic gel
Topical application of DBI-002 probiotic gel on skin affected with tinea versicolor
干预措施: DBI-002 probiotic gel (Biological)
Aqueous gel
Topical application of aqueous gel on skin affected with tinea versicolor
干预措施: Aqueous gel (Biological)
结局指标
主要结局
Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor)
时间窗: 14 days of participation
The primary analysis will summarize the number of subjects with more qPCR DBI-002 drug product and more improvement in qPCR Malassezia (fungal cause of tinea versicolor) between DBI-002 Drug Product (Active) and aqueous gel (Control) at Day 5 or Day 14 versus Baseline.
次要结局
- Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion(14 days of participation)