NCT01032499Unknown3 期
Multicenter Clinical Study,Phase III, Prospective, Randomized, Open and Comparative to Measure Tolerability and Efficacy of Taro Elixir on the Evolution Treatment of Acne Vulgaris II and III Degree or of Furunculosis Compared With Oxytetracycline
Laboratorios Goulart S.A.3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Measure the efficacy in the treatment of boils or acne vulgaris II and III degree with taro elixir compared with Oxytetracycline.
研究概览
简要总结
To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils or 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
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both of gender patient, older than 14 years;
- •Patient with boils or acne vulgaris II or III degree;
- •The score must be at least than 4, for 2 or more question of VAS (visual analog scale);
- •Patient that have been used an effective contraceptive method in the last 3 months, including sexual abstinence and that keep using that method during the study until a month after;
- •Patient that have been accepted to participate of the study and signed the Informed Consent or in case of younger than 18 years, the responsable must read and sign the Informed Consent.
- •Patient that have been accepted to meet all the visits stipulated at the protocol, whenever the investigator request in .
排除标准
- •Patient of female gender that has been pregnant, breastfeeding or that has not been use a safe contraceptive method (oral contraceptives or barrier methods). Sexual abstinence will be accept if the investigator think that it is relevant.
- •Patient that has been use antiandrogens (cyproterone, finasteride, flutamide, tamoxifen, spironolactone);
- •Patient with acne I or IV degree;
- •Patient that has been receive some treatment for acne as antibiotics, corticosteroid or any medicine that can maybe interfere in the study results: a month for systemic treatment or two weeks for topic treatment, before inclusion or during the study;
- •Patient that received treatment with oral retinoids within 6 months before the inclusion and during the study;
- •Patient that had a known decompensated diabetes history;
- •Patient with immunodeficiency and liver, renal, cardiac, digestive, metabolic, endocrinological, hematological, neurological or psychiatric disorders, evaluated through anamnesis by the investigator, tha can maybe interfere on the study evaluation. Even the patient with facial dermatoses such as psoriasis, acne rosacea, allergic dermatitis, skin infections caused by fungi, bacteria and viruses;
- •Patient with alcoholism history, illicit drugs use, psychological ou emotional problems that can maybe void the Informed Consent or limit the capacity of the patient follow the protocol requirements ;
- •Patient hypersensitive to any one of the medicine components;
- •Patient that have been used any drug under search, 3 months before the visit number one.
研究组 & 干预措施
oxytetracycline
Active Comparator
干预措施: oxytetracycline, taro elixir (Drug)
Taro Elixir
Experimental
Taken orally one tablespoon (15 mL) of Taro Elixir 3 times daily for breakfast, lunch and dinner.
干预措施: Taro Elixir (Drug)
结局指标
主要结局
Measure the efficacy in the treatment of boils or acne vulgaris II and III degree with taro elixir compared with Oxytetracycline.
时间窗: 90 days
次要结局
- Measure the tolerability in the treatment evolution of boils or acne vulgaris II and III with taro elixir compare with Oxytetracycline.(90 days)
研究者
研究点 (3)
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