Pyoderma
Conditions
Brief summary
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.
Interventions
Dioxidin®, 0.025% solution for local and external use (Valenta Farm, Russia).
DRUGBenzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium
Miramistin®, topical solution 0.01% (Infamed K LLC, Russia)
Sponsors
Valenta Pharm JSC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women between the ages of 18 and 65 years inclusive. 2. Signed informed consent form to participate in the study. 3. Patients with superficial pyoderma of different localization. 4. Body surface lesion area ≤ 5%. 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). 6. 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.
Exclusion criteria
1. Hypersensitivity to the active and/or excipients of the studied drugs. 2. Presence of signs of acute respiratory infections. 3. Deep pyoderma (furunculus, carbuncle, abscess, hydradenitis, etc.). 4. Use of local and systemic antibacterials, antiseptics, glucocorticosteroids, and antifungal agents less than 14 days prior to the screening visit. 5. Presence of infectious diseases requiring topical and/or systemic antibacterial therapy. 6. Vaccination of the patient less than 1 week prior to the screening visit. 7. Adrenal insufficiency. 8. Body temperature \>37C. 9. Fungal, viral skin infections, severe generalized bacterial skin lesions, other skin diseases. 10. Immunodeficiency states. 11. Positive HIV, Hepatitis B and C, or syphilis, or SARS-CoV-2 rapid test (COVID-19) 12. 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-19. 13. Scalp lesion (where treatment procedures and effectiveness cannot be adequately evaluated due to thick/long hair). 14. Allergic reactions to antibacterial drugs, antiseptic drugs in history. 15. Diabetes mellitus type 1 or 2. 16. 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). 17. 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. 18. 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). 19. The need for concomitant therapy with any of the drugs listed as Prohibited Concomitant Treatment. 20. History of alcohol and/or drug dependence. 21. Participation in another clinical trial less than 3 months prior to the Screening Visit. 22. Pregnancy. 23. Breastfeeding period. Withdrawal Criteria: 1. Withdrawal of Informed Consent by the patient. 2. Patient does not meet inclusion criteria. 3. Patient is found to have non-inclusion criteria. 4. Patient's desire to stop their participation in the study at any stage of the study. 5. Researcher's decision that continued participation in the study is contrary to the patient's best interests. 6. The investigator's decision to exclude the patient from the study due to a serious deviation from/breach of protocol. 7. Identification of a probable or confirmed COVID- 19 case (according to the Standard COVID-19 case definition). 8. An undesirable event requiring withdrawal of study therapy, or prescription of drugs from the Prohibited Complementary Treatment section, or limiting protocol procedures. 9. Patient's failure to show up for any visit and loss of communication with the patient. 10. Patient's omission of a cumulative total of more than 5 doses of medication throughout the treatment period or 3 consecutive doses. 11. Pregnancy. 12. Termination of the study by the sponsor. 13. Termination of the study by the investigator. 14. Termination of the study by the regulatory agency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who experienced complete cure of the disease at Visit 4 | 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 \[maximal severity of the symptom\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability: complete blood count - lymphocytes | Screening, Day 10 | Lymphocytes, % |
| 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 | Each symptom will be assessed from 0 (the absence of symptom) to 3 (maximal severity of the symptom) |
| 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 | The symptom will be assessed from 0 (the absence of symptom) to 3 (maximal severity of the symptom) |
| 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 | The symptom will be assessed from 0 (the absence of symptom) to 3 (maximal severity of the symptom) |
| 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 | The symptom will be assessed from 0 (the absence of symptom) to 3 (maximal severity of the symptom) |
| 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 | The symptom will be assessed from 0 (the absence of symptom) to 3 (maximal severity of the symptom) |
| 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 | The symptom will be assessed from 0 (the absence of symptom) to 3 (maximal severity of the symptom) |
| Average patient satisfaction with treatment at Visit 2, 3 and 4 | Day 4, Day 7, Day 10 | The satisfaction will be assessed from 0 (not satisfied) to 3 (absolutely satisfied) |
| Safety and Tolerability: vital signs - systolic blood pressure (SBP) | Screening, Day 1, Day 4, Day 7, Day 10 | SBP, mmHg |
| Safety and Tolerability: vital signs - diastolic blood pressure (DBP) | Screening, Day 1, Day 4, Day 7, Day 10 | DBP, mmHg |
| Safety and Tolerability: vital signs - heart rate (HR) | Screening, Day 1, Day 4, Day 7, Day 10 | HR, beats per minute |
| Safety and Tolerability: vital signs - body temperature | Screening, Day 1, Day 4, Day 7, Day 10 | Body temperature, centigrade scale |
| Safety and Tolerability: physical examination results | Screening, Day 1, Day 4, Day 7, Day 10 | Physical examination will follow the general rules of internal medicine: general examination, examination of mucous membranes and skin, including palpation of lymph nodes, evaluation of the musculoskeletal system, palpation, percussion, and auscultation of the main organ systems (cardiovascular, respiratory, digestive, and urinary systems) will be performed sequentially. The findings (if any) will be reported as the rate of clinically significant findings by each system level assessed. |
| Safety and Tolerability: complete blood count - hemoglobin | Screening, Day 10 | Hemoglobin, g/dL |
| Safety and Tolerability: complete blood count - red blood cells | Screening, Day 10 | Red blood cells, 10\^6/uL |
| Safety and Tolerability: complete blood count - hematocrit | Screening, Day 10 | Hematocrit, % |
| Safety and Tolerability: complete blood count - platelets | Screening, Day 10 | Platelets, 10\^3/uL |
| Safety and Tolerability: complete blood count - white blood cells | Screening, Day 10 | White blood cells, 10\^3/uL |
| Safety and Tolerability: complete blood count - eosinophils | Screening, Day 10 | Eosinophils, % |
| Safety and Tolerability: complete blood count - monocytes | Screening, Day 10 | Monocytes, % |
| Safety and Tolerability: complete blood count - basophils | Screening, Day 10 | Basophils, % |
| Safety and Tolerability: complete blood count - neutrophils | Screening, Day 10 | Neutrophils, % (segmented and stab) |
| Safety and Tolerability: blood test results - glucose | Screening, Day 10 | Glucose in blood serum, mmol/L |
| Safety and Tolerability: blood test results - total cholesterol | Screening, Day 10 | Total cholesterol in blood serum, mmol/L |
| Safety and Tolerability: blood test results - total bilirubin | Screening, Day 10 | Total bilirubin in blood serum, umol/L |
| Safety and Tolerability: blood test results - total protein | Screening, Day 10 | Total protein in blood serum, g/L |
| Safety and Tolerability: blood test results - creatinine | Screening, Day 10 | Creatinine in blood serum, umol/L |
| Safety and Tolerability: blood test results - urea | Screening, Day 10 | Urea in blood serum, mmol/L |
| Safety and Tolerability: blood test results - aspartate transaminase (AST) | Screening, Day 10 | AST in blood serum, U/L |
| Safety and Tolerability: blood test results - alanine transaminase (ALT) | Screening, Day 10 | ALT in blood serum, U/L |
| Safety and Tolerability: blood test results - alkaline phosphatase (ALP) | Screening, Day 10 | ALP in blood serum, U/L |
| Safety and Tolerability: urinalysis - specific gravity | Screening, Day 10 | Specific gravity of the urine |
| Safety and Tolerability: urinalysis - color | Screening, Day 10 | Color of the urine, visual assessment (pale yellow, yellow, amder, brown etc.) |
| Safety and Tolerability: urinalysis - transparency | Screening, Day 10 | Transparency of the urine, visual assessment (transparent or cloudy) |
| Safety and Tolerability: urinalysis - pH | Screening, Day 10 | pH of the urine |
| Safety and Tolerability: urinalysis - protein | Screening, Day 10 | Protein in the urine (g/L) |
| Safety and Tolerability: urinalysis - glucose | Screening, Day 10 | Glucose in the urine (mmol/L) |
| Safety and Tolerability: urinalysis (microscopy) - red blood cells | Screening, Day 10 | Red blood cells in the urine (number in sight) |
| Safety and Tolerability: urinalysis (microscopy) - white blood cells | Screening, Day 10 | White blood cells in the urine (number in sight) |
| Safety and Tolerability: urinalysis (microscopy) - epithelial cells | Screening, Day 10 | Epithelial cells in the urine (number in sight) |
| Safety and Tolerability: complete blood count - erythrocyte sedimentation rate | Screening, Day 10 | Erythrocyte sedimentation rate, mm per hour |
| Safety and Tolerability: urinalysis (microscopy) - bacteria | Screening, Day 10 | Bacteria in the urine (number in sight) |
| Safety and Tolerability: urinalysis (microscopy) - mucus | Screening, Day 10 | Presence of mucus in the urine |
| 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) | Number and frequency of adverse events (AEs) or serious AEs (SAEs) |
| Safety and Tolerability: local reactions | From the date of screening (and signing informed consent form) to the end of the study (Day 17) | Local reactions at the site of application will be evaluated separately on a 4-point scale (0 - no local reaction, 1 - weak local reaction in a limited area at the site of application, 2 - moderate local reaction in a limited/all area of application, 3 - strong local reaction in the whole area of application or going beyond it) |
| Safety and Tolerability: urinalysis (microscopy) - cylinders | Screening, Day 10 | Cylinders in the urine (number in sight) |
Countries
Russia
Outcome results
None listed