EUCTR2015-002637-21-BG进行中（未招募）1 期
An Open-Label, Long-Term Extension Study to Evaluate the Safety of Cortexolone 17a-Propionate (CB-03-01) Cream, 1% Applied Twice-Daily in Subjects with Acne Vulgaris - not available
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
入选标准
- •1. Subject must have been enrolled in one of the Phase 3 pivotal studies (CB-03-01/25 and CB-03-01/26), completed the assigned
- •treatment regimen without any material non-compliance with study requirements or test article dosing (compliance =80%), and
- •completed the final study visit (Visit 4-Pivotal).
- •2. Subject agrees to treat his/her facial acne and truncal acne (if designated by investigator AND desired by subject) during the
- •nine month study period per protocol. Note: Subjects who are clear (IGA=0) at Visit 4-Pivotal are also eligible for this study.
- •3. Females must be post-menopausal1, surgically sterile2, or using highly effective birth control methods.3,4 Women of
- •childbearing potential (WOCBP)5 must have a negative urine pregnancy test (UPT) at Visit 4-LTF (or Visit 4-Pivotal, if the visits
- •occur on the same day).
- •4. Subject has provided written informed consent/assent. A subject under 18 years of age must provide written informed assent
- •and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must
- •provide informed consent for the subject. If a subject becomes 18 years of age during the study, the subject must provide written
- •informed consent at that time to continue study participation.
- •5. Subject is willing to comply with study instructions and return to the clinic for required visits.
- •during the study, the subject must provide written informed consent at
- •that time to continue study participation.
- •3. Subject has an Investigator’s Global Assessment (IGA) score of 3 or 4 [0
- •(clear) to 4 (severe) scale].
- •4. Subject has facial acne vulgaris, which can include the nose, with at least
- •30 to a maximum of 75 inflammatory lesions (papules, pustules, and
- •nodules) and 30 to a maximum of 100 non-inflammatory lesions (open
- •and closed comedones).
- •5. Subject and parent/guardian (if applicable) are willing to comply with
- •study instructions and return to the clinic for required visits.
- •6. Subject has used the same type and brand of make-up, other facial
- •products (exclusive of RX/OTC acne cleansers) and hair products (e.g.,
- •shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to
- •the Baseline Visit and agrees to continue his/her other general skin and
- •hair care products and regimen for the entire study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 359
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •2. Subject has any skin pathology or condition that could interfere with the safety evaluation of the test products or requires the
- •use of interfering topical or systemic therapy (see Section 8.1: Prohibited Medications and Therapies).
- •3. Subject has any condition which, in the investigator’s opinion, would make it unsafe or unsuitable for the subject to participate
- •in this research study.
- •4. Subject plans to use any other investigational drug or device during participation in this study.
- •5. Subject, and parent/guardian if required, is unable to communicate or cooperate with the investigator due to language
- •problems, poor mental development, or impaired cerebral function.
- •6. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subject who
- •is unable to return for scheduled follow-up visits.
- •7. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test article.
- •8. Subject is or plans to use any topical anti-acne preparations (excluding CB-03-01 cream) or procedures on the face (or trunk, if
- •applicable) or any systemic anti-acne medications (as detailed in Section 8.1: Prohibited Medications and Therapies) during the
研究者
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