Clinical Study of Non-inferiority (Phase 2), Comparing Dapaconazole (BL123 - Biolab Sanus Farmacêutica Ltda.) Versus Miconazole Nitrate (União Química) in Patients With a Single Lesion of Tinea Cruris.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Proportion of participants with therapeutic cure.
研究概览
简要总结
This trial aims to evaluate the efficacy of dapaconazole tosylate 2% cream in the treatment of Tinea cruris compared to the active control miconazole nitrate 2% cream in patients with a single lesion.
详细描述
This is a phase 2, non-inferiority, monocentric, double-blind, randomized (allocation of treatment), balanced, controlled (active comparator) trial, with two parallel groups.
Randomization depended on inclusion/exclusion criteria, taking into account the confirmation of diagnosis by the direct mycological test and culture performed during the screening phase.
Participants showed up to the clinic, for treatment, during 14 consecutive days, when one of the investigational products (according to the randomization) was applied by a blind member of the study staff. A non-blind member of the study staff weighed the corresponding investigational product and passed on to the blind member only a spatula with the weighed product, in order to maintain the blinded aspect of the trial.
For exploratory purposes, clinical and mycological evaluations was also performed after 7 and after 14 days of treatment.
Safety analysis was performed considering all the randomized patients to which at least one dose of the investigational products has been applied, regardless of the result of the fungal culture.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged from 18 to 65 years old, male, or female with no childbearing potential or who are using an effective contraceptive method and who do not plan to become pregnant during the study period.
- •Presence of dermatological lesion of Tinea cruris, with an area not exceeding 8 cm², having, also, the diagnosis confirmed by direct mycological (KOH) test and fungus culture.
- •No previous treatment with antimycotic medication for the current dermatologic lesion.
- •No evidence of other significant diseases, that, at the investigator's discretion, may affect the participation in the clinical trial, in accordance with the protocol requirements.
- •Ability to understand the nature and the objective of the clinical trial, including the risks and possible side effects; intention to cooperate with the investigator and act in accordance with the protocol requirements, as confirmed by the informed consent form signature.
排除标准
- •Known hypersensitivity to miconazole or to chemically related compounds (azoles) or to the compounds of the investigational products.
- •Existing hepatic and/or renal diseases or other pathologic findings, which might interfere with the safety and tolerability of the active ingredients.
- •Screening laboratory tests presenting deviations deemed as clinically significant, which, due to possible risks, prevents the participation in clinical trial.
- •Treatment, within 3 months prior to the start of the clinical trial treatment, with any drug known to have a well-established toxic potential to major organs.
- •Pregnant or lactating women
- •Participation in any clinical trial, or intake of any investigational product, within the last six months prior to the inclusion in the clinical trial.
- •History of drug addiction.
- •Any prior treatment for the present lesion which, at investigator discretion, may interfere with the objectives of the clinical trial.
- •Participants who has any condition that prevents him from participating in the study according to the investigator's judgment.
研究组 & 干预措施
Group 1 - dapaconazole cream 2%
Topical application of dapaconazole cream 2%, twice a day (7 to 8 a.m. and 6 to 7 p.m.) for 14 days.
干预措施: Dapaconazole (Drug)
Group 2 - miconazole cream 2%
Topical application of miconazole cream 2%, twice a day (7 to 8 a.m. and 6 to 7 p.m.) for 14 days.
干预措施: Miconazole Nitrate (Drug)
结局指标
主要结局
Proportion of participants with therapeutic cure.
时间窗: 14 days of treatment
Proportion of participants, in each treatment group, who achieved therapeutic cure, defined as both clinical and mycological cure, on the assessment performed after 14 days of treatment. Clinical cure was considered when there was no more scaling of the lesions, total absence of erythema, itching and desquamation. Mycological cure was defined as negative result for the direct mycological examination (potassium hydroxide \[KOH\] test) and a negative fungal culture.
次要结局
- Number of adverse events per participant(up to 30 days)
- Number of days until clinical cure(up to 14 days)
研究者
Gilberto De Nucci
Doctor
Galeno Desenvolvimento de Pesquisas Clínicas