EUCTR2010-022678-15-DE进行中（未招募）不适用
A Phase 4 Open-Label Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-110 Gel (ACANYA™ Gel) in Subjects with Acne Vulgaris
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female of any race, at least 18 years of age;
- •2.Verbal and signed written informed consent obtained from the subject;
- •3.Has a clinical diagnosis of acne vulgaris with a score of 3 (moderate) or 4 (severe) on the EGSS assessment at the Screening and Day 0 Visits;
- •4.Presence of 17 to 40 inflammatory lesions (papules, pustules, and nodules) on the face (excluding the nose) at the Screening and Day 0 Visits;
- •5.Presence of 20 to 100 non-inflammatory lesions (open and closed comedones) on the face (excluding the nose) at the Screening and Day 0 Visits;
- •6.If female of childbearing potential, has a negative urine pregnancy test at the Screening and Day 0 visits, and must be willing to use an effective method of contraception during the study. Effective contraception is defined as a failure rate of less than 1 % per year when used consistently and correctly such as some intrauterine devices (IUD), condom with spermicide, diaphragm with spermicide, or stable use of a hormonal contraceptive (oral, implant, injection or transdermal patch) for at least 3 months prior to the Screening visit. (Females using birth control pills must have taken the same type of pill for at least 3 months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least 3 months prior to study entry);
- •7.Subject is willing to comply with study instructions and return to the clinic for all required visits;
- •8.Subjects must agree not to change their usual moisturizers, sunscreens, or moisturizer/sunscreen combination products during the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Presence of more than 2 nodules or cysts on the face;
- •Female who is pregnant, nursing an infant, or planning a pregnancy during the study period;
- •Presence of a surgical or medical condition that, in the judgement of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the study drug;
- •Presence of any other dermatological condition on the face that could interfere with the study evaluations
- •Treatment with any investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to the Screening Visit, or concurrent participation in another clinical study with an investigational drug or device;
- •Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;
- •Evidence or history of cosmetic-related acne;
- •History of experiencing significant burning or stinging when applying any facial treatment (e.g., make-up, soap, masks, washes, sunscreens, etc) to their face;
- •Use of medical products as described under point 10.4. of the protocol
- •If female, subject has a history of hirsutism, polycystic ovarian disease or clinically significant menstrual irregularities;
- •History of gastrointestinal disieases as described in the protocol;
- •Treatment with antiperistaltic agents such as opiates and diphenoxylate with atropine within four weeks prior to the first administration of investigational drug in this study and during the study;
- •Treatment of any type of cancer within the last 6 months;
- •Subject intends to use a tanning booth or sunbathe during the study;
- •Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function;
- •Subject with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject’s safety while participating on the study;
- •Subject has donated blood within 3 months prior to Day 0 or plans to donate blood during the study.
研究者
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