NCT00838812已完成3 期
Monocentric Study, Prospective, Open and Non Controlled for to Evaluate the Effectiveness, and Tolerability the Safety of Association of Clindamycin Phosphate 1.2% and Tretinoin 0,025% in the Treatment of Acne Vulgaris Mild to Moderate, When Used Once Daily for 12 Weeks.
Igefarma Laboratorios S.A.1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2009年3月最近更新:
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
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Evaluation of the efficacy, through number of lesions, and tolerability of the product.
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of association between tretinoin and clindamycin phosphate on the treatment of acne vulgaris mild and moderate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals of both sexes with age greater than or equal to 12 years
- •Subjects diagnosed with acne vulgaris in the face, except for the nasal area, range from mild to moderate, with the following requirements.
- •Mild acne = presence of fewer than 20 comedones or less than 15 lesions, inflammatory lesions or a total of less than 30 injuries.
- •Moderate acne = presence of 20 the 100 comedones or of 15 the 50 inflamatory lesions or a total of 30 the 125 lesions, with not more than lesions small nodule until 5,0 mm.
- •Ensure that the existing injuries were not submitted any treatment for acne, topical or systemic, within the last 30 days.
- •Be able to properly follow the determinations of the Protocol.
- •Has provided a written voluntary consent to participate in the study, by signing the informed consent, before being subjected to any procedure.
- •Under 18 years old, be accompanied by legal guardian in the process of obtaining the informed consent.
- •Be mentally able to provide consent and be fulfilling all the requirements of the study.
排除标准
- •Pregnant women or in periods of lactation.
- •Women of childbearing age and sexual activity with not using safe contraceptive method, such as oral contraceptives, implantable, injectable or intra-uterine, introduced for at least 120 days.
- •Women who are using oral contraceptives containing the hormone combination for acetate ciprosterone and etinolestradiol, association of drospirenone and ethinyl estradiol, or desogestrel.
- •Clinical evidence or history of immunodeficiency.
- •Any use of immunosuppressive drug and/or immunomodulating over the past 3 months, topical or systemic.
- •Concurrent use of fotossentetizadores, neuromuscular blockers, medications that exacerbate the acne, blockers (filters) with solar alcoholic vehicle, spironolactone, flutamide or zinc salts.
- •Prior use of systemic retinoid.
- •Presence of acne medication and/or cosmetic.
- •History of systemic metabolic disorder that can interfere with the integrity of the skin.
- •History of inflammatory disease, intestinal or regional enteritis and/or symptoms similar.
- •History of joy to any of the components of the formula (active principle or carrier).
- •History of abuse of alcohol and/or illegal drugs.
- •History of non-adherence to medical treatment earlier.
- •Any clinical observation made by the investigator that prohibits participation in the study of the subject.
研究组 & 干预措施
clindamicin and tretinoin gel
Other
干预措施: application of the topic gel (Drug)
结局指标
主要结局
Evaluation of the efficacy, through number of lesions, and tolerability of the product.
时间窗: three months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
暂停
2 期
Efficiency And Safety Of Association Arbutin, Triamcinolone And Tretinoin In Treatment Of MelasmaMelasmaNCT00717652Azidus Brasil110
已完成
2 期
Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission TherapyAcute Promyelocytic LeukemiaNCT01404949Memorial Sloan Kettering Cancer Center17
已完成
2 期
Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and WrinklesPhotodamaged SkinWrinklesNCT01283464Johns Hopkins University24
招募中
1 期
Study of Trametinib and Ruxolitinib in Colorectal Cancer and Pancreatic AdenocarcinomaPancreatic AdenocarcinomaColorectal CancerNCT04303403National Cancer Centre, Singapore48
已完成
早期 1 期
A Study Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% in the Treatment of Acne VulgarisAcne VulgarisNCT04724473Taro Pharmaceuticals USA1,030