NCT00357916已完成1 期
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of PEP005 Topical Gel (0.01% Concentration) in Healthy Volunteers Using a Repeat Insult Patch Test Design
Peplin2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2006年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To determine the sensitization potential of PEP005 Topical Gel (0.01% concentration) on normal skin.
研究概览
简要总结
To determine the sensitisation potential of PEP005 Topical Gel (0.01% concentration) on normal skin
To evaluate skin irritation
详细描述
This is a repeat insult patch test study. On treatment days, the investigational product PEP005 Topical Gel (0.01% concentration) and vehicle control will be applied under open conditions to sites on the infrascapular region of the back 3 times weekly for 3 weeks (9 applications in total) during the induction phase. Following a rest period of approximatley 10-14 days, a single challenge application will be performed. Local tolerability will be assessed visually using an ordinal scoring system. If a cutaneous response observed in the challenge phase indicates possible sensitisation, or at the discretion of the investigator, a rechallenge will occur
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- 是
入选标准
- •are healthy males or females (to be confirmed by medical history);
- •are between 18 and 65 years of age;
- •have Fitzpatick skin type I, II, III, or IV
- •are willing to wait 6 hours after product application to shower;
- •in the case of females of childbearing potential, are using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm, or abstinence), have a negative urine pregnancy test at Screening, and submit to a pregnancy test prior to the challenge application;
- •are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
- •have acceptable vital signs (ie oral body temperature, blood pressure (systolic and diastolic), and pulse rate) taken and are willing to have them taken at the end of study (EOS, within 7 days of the initial challenge evaluation);
- •complete a medical screening procedure; and
- •read, understand and provide signed informed consent.
排除标准
- •have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
- •have Fitzpatrick skin type V or VI;
- •have excessive hair on their back;
- •current drug or alcohol abuse;
- •have a clinically significant illness that may influence the outcome of the study within the 4 weeks prior to and during the study;
- •are not willing to refrain from using topical/systemic analgesics such as aspirin, Aleve, Motrin, Advil, or Nuprin within 72 hours prior to and during the study (occasional use of Tylenol will be permitted);
- •based on the investigator's initial examination should not participate in the study (ie, non compliance, inability to understand the study and give adequate informed consent)
- •are using systemic/locally-acting medications which might counter or influence the study aim during the study and within 2 weeks prior to the beginning of the study (eg, antihistamines, or topical glucocorticosteroids);
- •are using systemic/locally-acting anti-inflammitories which might counter or influence the study aim during the study and within 72 hours prior to the beginning of the study;
- •are females who are pregnant, plan to become pregnant during the study, or are nursing a child;
- •have a known sensitivity or allergy to constituents present in the material being evaluated; and/or
- •have participated in any clinical testing of an investigational drug within 28-days or any clinical patch study within 14-days prior to or are currently participating in any clinical testing.
结局指标
主要结局
To determine the sensitization potential of PEP005 Topical Gel (0.01% concentration) on normal skin.
次要结局
- To evaluate skin irritation
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy VolunteersActinic KeratosisNCT00850681Peplin50
已完成
2 期
A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the HandActinic KeratosisNCT00544297Peplin12
已完成
1 期
A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy VolunteersActinic KeratosisNCT00850811Peplin30
已完成
1 期
To evaluate the safety of test products.CTRI/2020/03/023725The Himalaya Drug Company200
已完成
1 期
To study the safety of test products on the skin.CTRI/2020/06/026085The Himalaya Drug Company200