A Multicenter, Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate Efficacy, Safety and Tolerability of a Fixed Dose Combination of Microsphere Tretinoin 0.1% and Clindamycin 1.2% Gel Compared to Individual Components of the Fixed Dose Combination in Patients with Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 438
- 试验地点
- 21
- 主要终点
- 2.Investigator’s Static Global Assessment Success
研究概览
简要总结
This is double-blind, randomized, active controlled, three arm, parallel-group, comparative study. Study will enroll 438 patients with acne vulgaris across the different centers from India. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting randomization criteria) in 1:1:1 ratios to receive either Fixed Dose Combination of Microsphere Tretinoin and Clindamycin gel or Clindamycin gel or Microsphere Tretinoin gel for twelve weeks. The primary objective of the study is to see the absolute change in lesion counts and Investigator’s Static Global Assessment success. Secondary objective includes; percentage change in lesion counts, proportion of patients who had a Subject Global Assessment Score of 0 or 1 at Week 12, proportion of patients who had an ISGA score of 0 or 1 at Week 12 and safety evaluation.
During the study, there will be 5 study visits at day 1, week 2, 4, 8 and 12 for efficacy, safety and tolerability assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female ≥12 to <65 years and willing to give their written informed consent.
- •2.An Investigator’s Static Global Assessment (ISGA) Score of 2 or greater at baseline 3.Subjects must have both: a)A minimum of 17 but no more than 40 facial inflammatory lesions; b)A minimum of 20 but not more than 150 facial non-inflammatory lesions 4.The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- •5.Female participants must have a negative pregnancy test at screening visit and willing to use acceptable contraceptive measures during the study.
- •6.The ability to understand and sign written informed consent form, which must have been obtained prior to applying the study product.
- •Subjects under the legal age of consent must provide assent and have the written informed consent of the parent or guardian.
排除标准
- •1.Pregnant or lactating women.
- •2.Patient with known hypersensitivity to any of the components of the formulation.
- •5.History or presence at entry of regional enteritis or inflammatory bowel disease or similar symptoms.
- •6.A significant medical history of or are currently immunocompromised.
- •8.Current drug or alcohol abuse at the time of entry 9.Any other condition which, in the judgment of the investigator, would put the Patient at unacceptable risk for participation in the study.
- •10.Patient who has clinical laboratory evaluations (including biochemistry, hematology, and complete urinalysis) that are not within the reference range for the testing laboratory at Screening and the results are deemed clinically significant by the investigator.
结局指标
主要结局
2.Investigator’s Static Global Assessment Success
时间窗: 12 weeks
1.Absolute Change in Lesion counts
时间窗: 12 weeks
次要结局
- 1.Percentage change in lesion counts
- 2.Proportion of patients who had a Subject Global Assessment Score of 0 or 1(12 weeks)
- 3.Proportion of Patients who had an ISGA Score of 0 or 1(12 weeks)
- 4.Change in Vital signs, Physical Exam. & Lab Parameters(12 weeks)