NCT05561816已完成3 期
Opened, Multicenter, Randomized, in Parallel Groups Comparative Study to Assess Efficacy and Safety of Dioxidin®, Solution for Topical and External Application 0.025% (Valenta Farm, Russia) and Miramistin®, Solution for Topical Application 0.01% (Infamed K LLC, Russia) in Treatment of Superficial Pyoderma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 10
- 主要终点
- Proportion of patients who experienced complete cure of the disease at Visit 4
研究概览
简要总结
The study is aimed to:
- evaluate the effectiveness of 10-day therapy with Dioxidin® compared with Miramistin® in the treatment of superficial pyoderma,
- evaluate the safety and tolerability of 10-day therapy with Dioxidin® compared with Miramistin® for the treatment of superficial pyoderma.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18 and 65 years inclusive.
- •Signed informed consent form to participate in the study.
- •Patients with superficial pyoderma of different localization.
- •Body surface lesion area ≤ 5%.
- •Patient's willingness and ability to comply with protocol requirements throughout the study (in particular, willingness to adhere strictly to the prescribed treatment regimen and to record the time of drug administration in the patient's diary).
- •Consent of study participant with preserved reproductive potential to use adequate methods of contraception (e.g., dual barrier method) throughout the study and for 3 weeks after study completion.
排除标准
- •Hypersensitivity to the active and/or excipients of the studied drugs.
- •Presence of signs of acute respiratory infections.
- •Deep pyoderma (furunculus, carbuncle, abscess, hydradenitis, etc.).
- •Use of local and systemic antibacterials, antiseptics, glucocorticosteroids, and antifungal agents less than 14 days prior to the screening visit.
- •Presence of infectious diseases requiring topical and/or systemic antibacterial therapy.
- •Vaccination of the patient less than 1 week prior to the screening visit.
- •Adrenal insufficiency.
- •Body temperature >37C.
- •Fungal, viral skin infections, severe generalized bacterial skin lesions, other skin diseases.
- •Immunodeficiency states.
- •Positive HIV, Hepatitis B and C, or syphilis, or SARS-CoV-2 rapid test (COVID-19)
- •Presence of at least one of the following epidemiologic indicators: Return from foreign travel 7 days prior to screening; Close contact in the last 7 days prior to screening with an individual under observation for COVID-19 who subsequently became ill; Close contact in the last 7 days prior to screening with an individual with a laboratory confirmed diagnosis of COVID-19; Professional contacts in the last 7 days prior to screening with individuals who have a suspected or confirmed case of COVID-
- •Scalp lesion (where treatment procedures and effectiveness cannot be adequately evaluated due to thick/long hair).
- •Allergic reactions to antibacterial drugs, antiseptic drugs in history.
- •Diabetes mellitus type 1 or
- •Any other comorbidities or conditions that, in the opinion of the investigator, make it difficult to interpret treatment results or make it impossible to perform procedures in this clinical trial or pose a risk to the patient when participating in the study (e.g., a history of severe allergies, atopic dermatitis in case the affected area overlaps with the area of pyoderma).
- •History of malignancy, with the exception of patients who have not had the disease in the past 5 years, patients with fully cured basal cell carcinoma of the skin, or fully cured carcinoma in situ.
- •Severe, decompensated, or unstable somatic diseases (any disease or condition that is life-threatening or worsens the patient's prognosis, or makes it impossible for the patient to participate in a clinical trial).
- •The need for concomitant therapy with any of the drugs listed as "Prohibited Concomitant Treatment".
- •History of alcohol and/or drug dependence.
- •Participation in another clinical trial less than 3 months prior to the Screening Visit.
- •Breastfeeding period.
- •Withdrawal Criteria:
- •Withdrawal of Informed Consent by the patient.
- •Patient does not meet inclusion criteria.
- •Patient is found to have non-inclusion criteria.
- •Patient's desire to stop their participation in the study at any stage of the study.
- •Researcher's decision that continued participation in the study is contrary to the patient's best interests.
- •The investigator's decision to exclude the patient from the study due to a serious deviation from/breach of protocol.
- •Identification of a probable or confirmed COVID- 19 case (according to the Standard COVID-19 case definition).
- •An undesirable event requiring withdrawal of study therapy, or prescription of drugs from the Prohibited Complementary Treatment section, or limiting protocol procedures.
- •Patient's failure to show up for any visit and loss of communication with the patient.
- •Patient's omission of a cumulative total of more than 5 doses of medication throughout the treatment period or 3 consecutive doses.
- •Termination of the study by the sponsor.
- •Termination of the study by the investigator.
- •Termination of the study by the regulatory agency.
研究组 & 干预措施
Dioxidin
Experimental
Patients will apply Dioxidin® 3 times a day (in the morning, afternoon and evening) by spraying (4 pressings of the spray nozzle on each affected area corresponding to 1% of the body area) on the affected skin areas from a distance of about 10 cm, so that the entire affected surface is covered with the solution. After application, you should wait until the preparation is completely dry. The therapy duration will be 10 days.
干预措施: Hydroxymethylquinoxalindioxyde (Drug)
Miramistin
Active Comparator
Patients will apply Miramistin® to the affected areas of the skin by wiping with sterile gauze swabs liberally moistened with the preparation three times a day (in the morning, lunchtime, and evening). The therapy duration will be 10 days.
干预措施: Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium (Drug)
结局指标
主要结局
Proportion of patients who experienced complete cure of the disease at Visit 4
时间窗: Day 10
In this study, cure will be considered achieved if the severity of each pyoderma symptom (painfulness on palpation, pustules/fluketens, hyperemia, inflammatory infiltration, edema) does not exceed 0 points (assessed from 0 \[the absence of symptom\] to 3 \[maximal severity of the symptom\])
次要结局
- Mean change in severity for the symptom "soreness on palpation" to Visits 2, 3 and 4 compared to baseline(Day 1, Day 4, Day 7, Day 10)
- Safety and Tolerability: complete blood count - platelets(Screening, Day 10)
- Safety and Tolerability: complete blood count - white blood cells(Screening, Day 10)
- Safety and Tolerability: complete blood count - monocytes(Screening, Day 10)
- Safety and Tolerability: urinalysis (microscopy) - cylinders(Screening, Day 10)
- Safety and Tolerability: urinalysis (microscopy) - bacteria(Screening, Day 10)
- Safety and Tolerability: urinalysis (microscopy) - mucus(Screening, Day 10)
- Safety and Tolerability: adverse event (AE) rate(From the date of screening (and signing informed consent form) to the end of the study (Day 17))
- Safety and Tolerability: local reactions(From the date of screening (and signing informed consent form) to the end of the study (Day 17))
- Mean change in the arithmetic mean change in pyoderma symptom severity scale, to Visits 2, 3, and 4 compared to baseline.(Day 1, Day 4, Day 7, Day 10)
- Safety and Tolerability: vital signs - systolic blood pressure (SBP)(Screening, Day 1, Day 4, Day 7, Day 10)
- Mean change in severity for the symptom "inflammatory infiltration" to Visits 2, 3 and 4 compared to baseline(Day 1, Day 4, Day 7, Day 10)
- Safety and Tolerability: vital signs - body temperature(Screening, Day 1, Day 4, Day 7, Day 10)
- Safety and Tolerability: physical examination results(Screening, Day 1, Day 4, Day 7, Day 10)
- Safety and Tolerability: complete blood count - hemoglobin(Screening, Day 10)
- Safety and Tolerability: complete blood count - red blood cells(Screening, Day 10)
- Safety and Tolerability: complete blood count - hematocrit(Screening, Day 10)
- Average change in the severity for the symptom "presence of pustules/flukteness" to Visits 2, 3 and 4 compared to baseline(Day 1, Day 4, Day 7, Day 10)
- Average change in the expression for the symptom "hyperemia" to Visits 2, 3 and 4 compared to baseline(Day 1, Day 4, Day 7, Day 10)
- Mean change in severity for the symptom "swelling" to Visits 2, 3 and 4 compared to baseline(Day 1, Day 4, Day 7, Day 10)
- Average patient satisfaction with treatment at Visit 2, 3 and 4(Day 4, Day 7, Day 10)
- Safety and Tolerability: vital signs - diastolic blood pressure (DBP)(Screening, Day 1, Day 4, Day 7, Day 10)
- Safety and Tolerability: vital signs - heart rate (HR)(Screening, Day 1, Day 4, Day 7, Day 10)
- Safety and Tolerability: complete blood count - erythrocyte sedimentation rate(Screening, Day 10)
- Safety and Tolerability: complete blood count - lymphocytes(Screening, Day 10)
- Safety and Tolerability: complete blood count - eosinophils(Screening, Day 10)
- Safety and Tolerability: complete blood count - basophils(Screening, Day 10)
- Safety and Tolerability: complete blood count - neutrophils(Screening, Day 10)
- Safety and Tolerability: blood test results - glucose(Screening, Day 10)
- Safety and Tolerability: blood test results - total cholesterol(Screening, Day 10)
- Safety and Tolerability: blood test results - total bilirubin(Screening, Day 10)
- Safety and Tolerability: blood test results - total protein(Screening, Day 10)
- Safety and Tolerability: blood test results - creatinine(Screening, Day 10)
- Safety and Tolerability: blood test results - urea(Screening, Day 10)
- Safety and Tolerability: urinalysis (microscopy) - white blood cells(Screening, Day 10)
- Safety and Tolerability: blood test results - aspartate transaminase (AST)(Screening, Day 10)
- Safety and Tolerability: blood test results - alanine transaminase (ALT)(Screening, Day 10)
- Safety and Tolerability: blood test results - alkaline phosphatase (ALP)(Screening, Day 10)
- Safety and Tolerability: urinalysis - specific gravity(Screening, Day 10)
- Safety and Tolerability: urinalysis - color(Screening, Day 10)
- Safety and Tolerability: urinalysis - transparency(Screening, Day 10)
- Safety and Tolerability: urinalysis - pH(Screening, Day 10)
- Safety and Tolerability: urinalysis (microscopy) - red blood cells(Screening, Day 10)
- Safety and Tolerability: urinalysis - protein(Screening, Day 10)
- Safety and Tolerability: urinalysis - glucose(Screening, Day 10)
- Safety and Tolerability: urinalysis (microscopy) - epithelial cells(Screening, Day 10)
研究者
研究点 (10)
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