CLINICAL EVALUATION OF EFFECTIVENESS OF ASSOCIATION MOMETASONE FUROATE 0.1% AND SALICYLIC ACID 5% COMPARED WITH 0.1% MOMETASONE FUROATE INSULATED TOPICAL USE OF LABORATORY Glenmark Pharmaceuticals Ltd, IN PATIENTS WITH PSORIASIS IN PLATE
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 40
- 主要终点
- Evaluating the effectiveness and comparative isolation of the association mometasone furoate + salicylic acid and the substance isolated mometasone furoate
研究概览
简要总结
The aims is to evaluate the efficacy and comparative isolation of the association Mometasone furoate + Salicylic Acid and the substance isolated Mometasone furoate produced by the Laboratory Glenmark Pharmaceuticals Ltd. in patients of both sexes, patients with plaque psoriasis grade mild to moderate.
详细描述
The specific objective is to evaluate through analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis. The study will be conducted with 40 patients who will deal with two symmetrical lesions of his body being identified by the clinician that a party should be treated in a double-blind only with mometasone furoate cream containing 0.1% and another with the combination of furoate of mometasone 0.1% + Salicylic Acid 5%. The group of patients to be treated must be adults of both sexes, aged 18-70 years with good mental and physical health to sign the Informed Consent and who are clinically assessed by dermatologists in the study as having mild plaque psoriasis and moderate. The association made a proposal of effectiveness was developed and is produced by the Laboratory Glenmark Pharmaceuticals Ltd., as well as its isolated version of the pilot (mometasone furoate 0.1%). This study should be characterized as Phase II multicenter not.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults of both sexes, regardless of color or social class;
- •Age 18 or older, with good mental health;
- •Patients with plaque psoriasis of mild to moderate;
- •Patients who agree to participate and sign the Informed Consent and
- •Clarified (appendix);
- •Patients who agree to return for follow-up visits.
排除标准
- •Patients who are making use of biologics, steroids or steroidal anti-inflammatory and non-steroidal or who made use of these topical medications until 15 days ago 30 days ago or when occurred in oral administration;
- •Patients who are exposing themselves to the sun 15 days before the study began or during the course of the same.
- •Patients who are making use of acetaminophen;
- •Patients who do not agree to the terms described in the informed consent Informed Consent;
- •Patients who also have psoriatic plaques of skin disorders caused by fungi or bacteria and who are making use of antimycotics or antibiotics;
- •Lions and other types of skin damage than those psoriasis;
- •Pregnant and nursing women;
- •Patients using oral anticoagulants.
研究组 & 干预措施
-mometasone furoate associated with salicylic acid
干预措施: mometasone furoate + salicylic acid (Drug)
-mometasone furoate
干预措施: Mometasone furoate (Drug)
结局指标
主要结局
Evaluating the effectiveness and comparative isolation of the association mometasone furoate + salicylic acid and the substance isolated mometasone furoate
时间窗: 2 months of treatment.
次要结局
- Evaluation by means of analytical propedeutics medical improvement in clinical signs and symptoms related to plaque psoriasis.(2 months of treatment.)
研究者
Azidus Brasil
Principal Investigator Dr. Alexandre Frederico
Azidus Brasil