NCT02800148已完成3 期
Bioequivalence Study of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea on the Face
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Padagis LLC
- 入组人数
- 667
- 试验地点
- 1
- 主要终点
- Percent Change (Reduction) of Lesion Count From Day 1
研究概览
简要总结
To compare the bioequivalence of Perrigo's azelaic acid foam product to Finacea Foam for the treatment of Inflammatory Lesions of Rosacea
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must sign an Institutional Review Board (IRB) approved written informed consent for this study.
- •Subjects must be at least 18 years of age.
- •Subjects must have a definite clinical diagnosis of moderate to facial papulopustular rosacea,
- •Subjects must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, refrain from use of all other
- •Subjects must be in general good health and free from any clinically significant disease, other than rosacea, that might interfere with the study evaluations.
- •Females of childbearing potential (excluding women who are surgically sterilized (verified tubal ligation or bilateral oophorectomy or hysterectomy) or post- menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1 (Baseline), must be willing to use an acceptable form of birth control during the study.
排除标准
- •Subjects, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.
- •Current or past ocular rosacea
- •Presence of any other facial skin condition that might interfere with rosacea diagnosis and/or assessment
- •Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial or, in judgment of the Investigator, would put the subject at undue risk or might confound the study assessments
- •Currently using any product containing Azelaic Acid/or belonging to the same family as Azelaic Acid foam, 15%.
- •Any use of Azelaic Acid Foam, 15%, 1 month (30 days) prior to baseline or throughout the study.
- •History of hypersensitivity or allergy to Finacea® (Azelaic Acid) Foam, 15%, and/or any ingredient in the study medication.
- •Use of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit 1/Day 1 (Baseline).
- •Current use of anticoagulation therapy and use throughout the study.
- •Use of medicated make-up (including anti-aging make-up) throughout the study
- •Use during the study of 1) systemic steroids, 2) topical retinoids to the face 3) antibiotics known to impact rosacea 4) immunosuppressive agents, or immunomodulators).
- •Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics.
- •Use of medicated cleansers on the face throughout the study.
- •Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements
- •Use of topical astringents or abrasives, medicated topical preparations (prescription and OTC products) within 2 days prior to Visit 1 and throughout the study.
- •Use of antipruritics (including antihistamines), spa treatments or chlorine exposure (swimming etc.) within 24 hours of all study visits.
- •Participation in any clinical study involving an investigational product, agent or device that might influence the intended effects or mask the side effects of study medication in the 1 month (30 days) prior Visit 1/Day 1 (Baseline) or throughout the study.
- •Previous enrollment in this study or current enrollment in this study at another participating site.
- •Use of tanning booths, sun lamps (excessive UV radiation e.g., phototherapy, daily extended exposure or occupational exposure to the sun), sunbathing or excessive exposure to the sun 1 week prior to baseline and throughout the study.
- •Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.
研究组 & 干预措施
Azelaic acid foam
Experimental
干预措施: Azelaic acid foam (Drug)
Finacea Foam
Active Comparator
干预措施: Azelaic acid foam (Drug)
Placebo Foam
Placebo Comparator
干预措施: Azelaic acid foam - Placebo (Drug)
结局指标
主要结局
Percent Change (Reduction) of Lesion Count From Day 1
时间窗: Day 84
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne VulgarisAcneNCT02525549Padagis LLC903
已完成
1 期
Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular RosaceaPapulopustular RosaceaNCT01257919LEO Pharma21
已完成
1 期
Semi-replicate Crossover Bioequivalence Study of Dirithromycin of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) in Healthy Subjects Under Fasting ConditionsHealthyNCT02237768Pharmaceutical Research Unit, Jordan48
已完成
1 期
Semi-replicate Crossover Bioequivalence Study of Dirithromycin in Healthy Subjects Under Fed ConditionsHealthyNCT02237807Pharmaceutical Research Unit, Jordan48
已完成
3 期
Comparative Safety and Efficacy of Two Treatments in the Treatment of Acne VulgarisAcneNCT02515305Padagis LLC890