Comparative Study of the Effect on Acne With Norgestimate Containing Triphasic Oral Contraceptive and Biphasic Preparation Containing Desogestrel
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 3
- 主要终点
- Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment of female participants with mild to moderate acne vulgaris (pimples).
详细描述
This is a single-blind (physician does not know the name of the assigned drug) and randomized (study drug assigned by chance) study to compare the effectiveness and safety of EE/NGM and EE/DSG in female participants using oral contraceptive and have mild to moderate acne vulgaris. Tablets of EE/NGM and EE/DSG will be administered orally once daily for 6 months and will be instructed to visit for evaluation at Month 1, 3 and 6 post-administration. The efficacy will be evaluated efficacy primarily through total acne lesions count, which will be recorded at these evaluation visits. Unused study medications will be collected and drug accountability will be documented. Participants' safety will be monitored throughout the study.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Needs contraception in the family planning - Mild to moderate acne vulgaris - Agrees to take only the supplied study drug as treatment for acne during the 6-month treatment phase of the study - Signs and dates an informed consent to participate in the study - female participants aged 18 to 45 years
排除标准
- •Pregnant or nursing - Known hypersensitivity to any of the ingredients and currently having significant adverse experiences from ethinyl estradiol, norgestimate or desogestrel - Any coexisting medical condition or were taking any concomitant medication that is likely to interfere with safe administration of ethinyl estradiol/norgestimate and ethinyl estradiol/desogestrel, in the Investigator's opinion - Taking system retinoids, systemic antimicrobials, and topical acne treatments within 6 months, 1 month, and 2 weeks prior to enrollment, respectively - Taking investigational medication or oral contraceptives within 30 days prior to Screening
研究组 & 干预措施
Ethinyl estradiol/Norgestimate (EE/NGM)
干预措施: Ethinyl estradiol/Norgestimate (EE/NGM) (Drug)
Ethinyl estradiol/Desogestrel (EE/DSG)
干预措施: Ethinyl estradiol/Desogestrel (EE/DSG) (Drug)
结局指标
主要结局
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
时间窗: Baseline and Month 1
Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 1. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3
时间窗: Baseline and Month 3
Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 3. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6
时间窗: Baseline and Month 6
Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 6. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.
次要结局
- Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6(Month 1, 3 and 6)
- Number of Participants Non-Compliant With Therapy(Month 1, 3 and 6)
- Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6(Baseline and Month 1, 3 and 6)
- Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6(Month 6)
- Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6(Month 6)
- Change From Baseline in Blood Pressure (BP) at Month 6(Baseline and Month 6)
- Change From Baseline in Body Weight at Month 6(Baseline and Month 6)