A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- To assess safety
研究概览
简要总结
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design To evaluate the sensitization potential
详细描述
MOB015B is a topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine. Terbinafine is a well-known antifungal agent that has been widely used for decades for both in topical and oral preparations and is regarded as an effective treatment of dermatophyte infections. In a phase II study, MOB015B was found to be efficacious and safe in the topical treatment of distal subungual onychomycosis. This Phase 1 study will assess the sensitization potential of MOB015B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
NA- Safety study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is a healthy male or female (to be confirmed by medical history);
- •Is 18 years of age or older;
- •In the case of a female of childbearing potential, is using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal ligation). Abstinence or vasectomies are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes;
- •In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);
- •Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs;
- •Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema (see Table 1);
- •Complete a medical screening procedure; and
- •Read, understand, and sign an informed consent.
排除标准
- •Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
- •Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
- •Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin (81 mg daily aspirin will be allowed), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen will be permitted);
- •Is using medication which, in the opinion of the Investigator, will interfere with the study results (e.g. anti-inflammatory medications, antipsychotics, anticonvulsants with potential pain relief effects, immunomodulatory medications, and others);
- •Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
- •Has psoriasis and/or active atopic dermatitis/eczema;
- •Has a known sensitivity or allergy to constituents of the materials being evaluated;
- •Is a female who is pregnant, plan to become pregnant during the study, or is breast feeding a child;
- •Has damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
- •Has received treatment for any type of internal cancer within 5 years prior to study entry;
- •Has a history of, or are currently being treated for skin cancer and/or hepatitis;
- •Has a history of, or is currently being treated for, insulin dependent diabetes;
- •Has any condition that might compromise study results;
- •Currently or expect to sunbathe or use tanning salons during the study;
- •Is currently participating in any clinical testing;
- •Has any known sensitivity to adhesives; and/or
- •Has received any investigational drug(s) within 4 weeks prior to study entry.
研究组 & 干预措施
MOB015B
Patches were applied to the infrascapular area
干预措施: MOB015B (Drug)
Vehicle
Patches were applied to the infrascapular area
干预措施: MOB015B vehicle (Drug)
Negative irritant solution (0.9% saline)
Patches were applied to the infrascapular area
干预措施: Negative irritant solution of 0.9% saline (Drug)
结局指标
主要结局
To assess safety
时间窗: 6 weeks
Evaluation of any adverse events (AEs) reported during the study.application to the healthy skin of humans.
To determine the potential of MOB015B to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions.
时间窗: 6 weeks
Evaluation of dermal reactions at the application sites assessed clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation.
次要结局
未报告次要终点