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A Safety and Efficacy Evaluation of Topical Treatments for Moderate-Severe Facial Acne Vulgaris

2017年7月27日 更新者：Braintree Laboratories

A Randomized, Controlled Evaluation of the Safety and Efficacy of Topical Treatments for Moderate-Severe Facial Acne Vulgaris

The objective of the study is to compare the safety and efficacy of multiple formulations of BLI1100 to a control group and placebo in treating patients with moderate-severe acne vulgaris.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

509

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35205
        • BLI Research Site 27
      • Mobile、Alabama、美国、36608
        • BLI Research Site 24
    • Arizona
      • Tucson、Arizona、美国、85745
        • BLI Research Site 51
    • Arkansas
      • Rogers、Arkansas、美国、72758
        • BLI Research Site 40
    • California
      • Chula Vista、California、美国、91911
        • BLI Research Site 57
      • Costa Mesa、California、美国、92626
        • BLI Research Site 56
      • Encino、California、美国、91436
        • BLI Research Site 18
      • Fremont、California、美国、94538
        • BLI Research Site 7
      • Upland、California、美国、91786
        • BLI Research Site 45
    • Colorado
      • Denver、Colorado、美国、80220
        • BLI Research Site 41
      • Wheat Ridge、Colorado、美国、80033
        • BLI Research Site 39
    • Florida
      • Hialeah、Florida、美国、33012
        • BLI Research Site 19
      • Jupiter、Florida、美国、33458
        • BLI Research Site 49
      • Miami、Florida、美国、33126
        • BLI Research Site 12
      • Miami Lakes、Florida、美国、33016
        • BLI Research Site 54
      • Ormond Beach、Florida、美国、32174
        • BLI Research Site 20
      • Port Saint Lucie、Florida、美国、34984
        • BLI Research Site 59
      • Saint Petersburg、Florida、美国、33709
        • BLI Research Site 15
      • Tampa、Florida、美国、33607
        • BLI Research Site 1
      • Tampa、Florida、美国、33609
        • BLI Research Site 29
      • Wellington、Florida、美国、33414
        • BLI Research Site 28
      • West Palm Beach、Florida、美国、33406
        • BLI Research Site 43
    • Indiana
      • Plainfield、Indiana、美国、46168
        • BLI Research Site 11
    • Kentucky
      • Louisville、Kentucky、美国、40202
        • BLI Research Site 33
    • Massachusetts
      • Beverly、Massachusetts、美国、01915
        • BLI Research Site 34
      • Quincy、Massachusetts、美国、02169
        • BLI Research Site 42
    • Michigan
      • Fort Gratiot、Michigan、美国、48059
        • BLI Research Site 37
    • Nebraska
      • Omaha、Nebraska、美国、68114
        • BLI Research Site 9
      • Omaha、Nebraska、美国、68144
        • BLI Research Site 47
    • New Hampshire
      • Newington、New Hampshire、美国、03801
        • BLI Research Site 5
    • New York
      • Stony Brook、New York、美国、11790
        • BLI Research Site 46
    • North Carolina
      • High Point、North Carolina、美国、27262
        • BLI Research Site 50
      • Wilmington、North Carolina、美国、28401
        • BLI Research Site 52
    • Ohio
      • Cincinnati、Ohio、美国、45255
        • BLI Research Site 32
    • Oklahoma
      • Norman、Oklahoma、美国、73071
        • BLI Research Site 55
    • Oregon
      • Gresham、Oregon、美国、97030
        • BLI Research Site 4
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19103
        • BLI Research Site 60
    • Rhode Island
      • Johnston、Rhode Island、美国、02919
        • BLI Research Site 10
    • Tennessee
      • Goodlettsville、Tennessee、美国、37072
        • BLI Research Site 53
      • Murfreesboro、Tennessee、美国、37130
        • BLI Research Site 58
      • Nashville、Tennessee、美国、37203
        • BLI Research Site 14
    • Texas
      • Beaumont、Texas、美国、77701
        • BLI Research Site 30
      • Bryan、Texas、美国、77802
        • BLI Research Site 6
      • Houston、Texas、美国、77056
        • BLI Research Site 3
      • New Braunfels、Texas、美国、78130
        • BLI Research Site 8
      • Pflugerville、Texas、美国、78660
        • BLI Research Site 44
      • San Antonio、Texas、美国、78249
        • BLI Research Site 16
    • Utah
      • Salt Lake City、Utah、美国、84117
        • BLI Research Site 21
    • Virginia
      • Norfolk、Virginia、美国、23507
        • BLI Research Site 26
    • Washington
      • Spokane、Washington、美国、99202
        • BLI Research Site 25

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 45年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Males or females 12 to 45 years of age, inclusive, in good general health.
  2. Clinical diagnosis of facial acne vulgaris

  3. Patients with an Investigator's Global Assessment severity score of at least 3 that meet the following lesion count criteria:

    • A minimum of 20 but not more than 50 inflammatory lesions (including the nose)
    • A minimum of 30 but not more than 100 non-inflammatory lesions on the face (including the nose)
    • No nodules are allowed on the entire face.
  4. Each patient or parent/guardian will read and sign the consent form as required by IRB regulations. Patients under the age of 18, but of sufficient age to provide assent (as determined by IRB regulations), will complete an assent form.
  5. Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication.
  6. Treatment with estrogens, androgens, or anti-androgenic agents for a non-contraceptive indication must be stable for 6 months prior to the first dose of study product and remain unchanged during the study.
  7. Patients who are willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.
  8. Patients who are mentally competent in the Investigator's judgment, to provide informed consent/assent to participate in the study

Exclusion Criteria:

  1. Patients who had been treated with:

    • systemic retinoids during a 6-month period before Visit 1 or by systemic antibiotics during a 4-week period before Visit 1
    • or by a topical treatment (eg, antibiotics, benzoyl peroxide, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid, dapsone) or systemic corticosteroids during a 2-week period before the first dose of study medication.
  2. History of hereditary angio-edema
  3. Pregnancy, lactation or patient, who is not practicing effective contraception.
  4. Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin.
  5. A known endocrine malfunction (hyperthyroidism, hypothyroidism, diabetes, adrenal insufficiency).
  6. Erythroderma, immunodeficiency disorders and Mycosis Fungoides
  7. History of Epilepsy or Parkinson's disease
  8. History of alcohol and/or drug abuse within 5 years of screening
  9. Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
  10. Any single facial skin condition assessment graded as "Severe" at Visit 1
  11. Using drugs known to be photosensitizers because of the possibility of increased phototoxicity.
  12. Refusal to cease using the following types of facial products: astringents, toners, abradants, facials, loofahs, peels containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide (BPO), hydroquinone, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids .
  13. Using medications that are reported to exacerbate acne .
  14. Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, during the 4 weeks prior to Visit 1.
  15. Unwilling to avoid excessive swimming and sun exposure to include artificial UV light exposure (tanning beds).
  16. Patients using comedogenic makeup.
  17. Have a known hypersensitivity or previous allergic reaction to any of the components .
  18. Employees of the clinical research site or organization involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
  19. Have a member of the same household in this trial.
  20. Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
  21. Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
  22. Patients who withdraw consent before completion of Visit 1 procedures

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：BLI1100-1
Topical gel
药品：BLI1100-1
BLI1100-1 Topical gel
实验性的：BLI1100-2
Topical gel
药品：BLI1100-2
BLI1100-2 Topical gel
实验性的：BLI1100-3
Topical gel
药品：BLI1100-3
BLI1100-3 Topical gel
实验性的：BLI1100-4
Topical gel
药品：BLI1100-4
BLI1100-4 Topical gel
安慰剂比较：Placebo
Topical gel
药品：Placebo
Placebo - Topical gel

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Absolute change in total lesion count
大体时间：12 weeks
12 weeks
Treatment success based on Investigator Global Assessment
大体时间：12 weeks
12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Braintree Laboratories

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年10月1日

初级完成 (实际的)

2016年6月1日

研究完成 (实际的)

2016年6月1日

研究注册日期

首次提交

2015年11月12日

首先提交符合 QC 标准的

2015年11月12日

首次发布 (估计)

2015年11月13日

研究记录更新

最后更新发布 (实际的)

2017年7月28日

上次提交的符合 QC 标准的更新

2017年7月27日

最后验证

2017年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • BLI1100-203

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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