NCT01556698已完成1 期
Single-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison, Proof of Concept Study Comparing the Tolerability, Safety and Efficacy of NVN1000 Topical Gel Gel Vehicle in the Treatment of Moderate to Severe Acne
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novan, Inc.
- 入组人数
- 70
- 试验地点
- 1
研究概览
简要总结
The primary objective of this study is to compare the tolerability, safety and efficacy of NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to severe acne vulgaris.
详细描述
The objective of this study is to evaluate the tolerability, safety and efficacy of once daily application of NVN1000 Topical Gel for 8 weeks in comparison with its vehicle in subjects with moderate to severe acne.
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
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Baseline IGA score of moderate (3) or severe (4)
- •Minimum of 20 but no more than 40 facial inflammatory lesions
- •Minimum of 20 but not more than 60 facial non-inflammatory lesions
- •No more than 2 facial nodules
排除标准
- •Dermatological conditions on the face that could interfere with clinical evaluations
- •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
- •History of experiencing significant burning or stinging when applying any facial treatment
- •Female subjects, if they are pregnant,nursing mothers, or planning to become pregnant during the study
- •Have used estrogens or oral contraceptives for less than 90 days immediately preceding the Baseline visit, discontinued use of estrogens or oral contraceptives less than 90 days prior to Baseline,or planning to begin or discontinue use of this therapy during the treatment period
- •Have used medications and/or vitamins which are reported to exacerbate acne during the 180 days immediately preceding the Baseline visit
- •Use concomitantly over-the-counter (OTC) products that contain ingredients such as benzoyl peroxide,salicylic acid,alpha-hydroxy acid,retinol or glycolic acids
- •Have not undergone the specified washouts for topical preparations,systemic medications and procedures noted in the protocol
研究组 & 干预措施
NVN1000 Gel
Experimental
NVN1000 Gel topically applied one daily at bedtime for 8 weeks
干预措施: NVN1000 (Drug)
Vehicle Gel
Placebo Comparator
Vehicle Gel topically applied once daily at bedtime for 8 weeks
干预措施: Vehicle (Drug)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract CancerBiliary Tract CancerNCT03785873University of Michigan Rogel Cancer Center34
招募中
1 期
The Safety and Effectiveness of NV-A01 in Glioma PatientsAdvanced Glioblastoma PatientsNCT06193538First Affiliated Hospital of Wannan Medical College15
已完成
2 期
Efficacy and Safety of NVC-422 in the Treatment of Adenoviral ConjunctivitisAdenoviral ConjunctivitisNCT01532336NovaBay Pharmaceuticals, Inc.500
已完成
3 期
A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS)Recurrent Herpes LabialisNCT01324466NanoBio Corporation847
已完成
3 期
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis BChronic Hepatitis BNCT00117676Gilead Sciences382