Efficacy and Safety of Dioxidin Versus Miramistin in Superficial Pyoderma

Valenta Pharm JSC240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Pyoderma

Interventions

HydroxymethylquinoxalindioxydeDRUG

Dioxidin®, 0.025% solution for local and external use (Valenta Farm, Russia).

Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azaniumDRUG

Miramistin®, topical solution 0.01% (Infamed K LLC, Russia)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (10)

Chelyabinsk Regional Clinical Dermatology and Venereology Dispensary

Chelyabinsk, Russia

Professor Gorbakov Clinic, LLC

Krasnogorsk, Russia

Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology of the Moscow Department of Health

Moscow, Russia

Outcomes

Primary Outcomes

Proportion of patients who experienced complete cure of the disease at Visit 4

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 \[maximal severity of the symptom\])

Time frame: Day 10

Secondary Outcomes

Mean change in the arithmetic mean change in pyoderma symptom severity scale, to Visits 2, 3, and 4 compared to baseline.

Each symptom will be assessed from 0 (the absence of symptom) to 3 (maximal severity of the symptom)

Time frame: Day 1, Day 4, Day 7, Day 10

Mean change in severity for the symptom "soreness on palpation" to Visits 2, 3 and 4 compared to baseline

The symptom will be assessed from 0 (the absence of symptom) to 3 (maximal severity of the symptom)

Time frame: Day 1, Day 4, Day 7, Day 10

Average change in the severity for the symptom "presence of pustules/flukteness" to Visits 2, 3 and 4 compared to baseline

The symptom will be assessed from 0 (the absence of symptom) to 3 (maximal severity of the symptom)

Time frame: 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

The symptom will be assessed from 0 (the absence of symptom) to 3 (maximal severity of the symptom)

Time frame: 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

The symptom will be assessed from 0 (the absence of symptom) to 3 (maximal severity of the symptom)

Data from ClinicalTrials.gov

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Federal State Budgetary Educational Institution of Higher Professional Education Ryazan State Medical University, Ministry of Health of Russia

Ryazan, Russia

Regional Clinical Dermatology and Venereology Dispensary

Ryazan, Russia

City Dermatological and Venereological Dispensary

Saint Petersburg, Russia

Northwestern Center for Evidence-based Medicine, JSC

Saint Petersburg, Russia

Private Health Care Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg

Saint Petersburg, Russia

Yakusi Clinic, LLC

Saint Petersburg, Russia

Clinic of Modern Medicine of Dr. Bogorodskaya, LLC

Yaroslavl, Russia

Time frame: 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

The symptom will be assessed from 0 (the absence of symptom) to 3 (maximal severity of the symptom)

Time frame: Day 1, Day 4, Day 7, Day 10

Average patient satisfaction with treatment at Visit 2, 3 and 4

The satisfaction will be assessed from 0 (not satisfied) to 3 (absolutely satisfied)

Time frame: Day 4, Day 7, Day 10

Safety and Tolerability: vital signs - systolic blood pressure (SBP)

SBP, mmHg

Time frame: Screening, Day 1, Day 4, Day 7, Day 10

Safety and Tolerability: vital signs - diastolic blood pressure (DBP)

DBP, mmHg

Time frame: Screening, Day 1, Day 4, Day 7, Day 10

Safety and Tolerability: vital signs - heart rate (HR)

HR, beats per minute

Time frame: Screening, Day 1, Day 4, Day 7, Day 10

Safety and Tolerability: vital signs - body temperature

Body temperature, centigrade scale

Time frame: Screening, Day 1, Day 4, Day 7, Day 10

Safety and Tolerability: physical examination results

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.

Time frame: Screening, Day 1, Day 4, Day 7, Day 10

Safety and Tolerability: complete blood count - hemoglobin

Hemoglobin, g/dL

Time frame: Screening, Day 10

Safety and Tolerability: complete blood count - red blood cells

Red blood cells, 10\^6/uL

Time frame: Screening, Day 10

Safety and Tolerability: complete blood count - hematocrit

Hematocrit, %

Time frame: Screening, Day 10

Safety and Tolerability: complete blood count - platelets

Platelets, 10\^3/uL

Time frame: Screening, Day 10

Safety and Tolerability: complete blood count - white blood cells

White blood cells, 10\^3/uL

Time frame: Screening, Day 10

Safety and Tolerability: complete blood count - erythrocyte sedimentation rate

Erythrocyte sedimentation rate, mm per hour

Time frame: Screening, Day 10

Safety and Tolerability: complete blood count - lymphocytes

Lymphocytes, %

Time frame: Screening, Day 10

Safety and Tolerability: complete blood count - eosinophils

Eosinophils, %

Time frame: Screening, Day 10

Safety and Tolerability: complete blood count - monocytes

Monocytes, %

Time frame: Screening, Day 10

Safety and Tolerability: complete blood count - basophils

Basophils, %

Time frame: Screening, Day 10

Safety and Tolerability: complete blood count - neutrophils

Neutrophils, % (segmented and stab)

Time frame: Screening, Day 10

Safety and Tolerability: blood test results - glucose

Glucose in blood serum, mmol/L

Time frame: Screening, Day 10

Safety and Tolerability: blood test results - total cholesterol

Total cholesterol in blood serum, mmol/L

Time frame: Screening, Day 10

Safety and Tolerability: blood test results - total bilirubin

Total bilirubin in blood serum, umol/L

Time frame: Screening, Day 10

Safety and Tolerability: blood test results - total protein

Total protein in blood serum, g/L

Time frame: Screening, Day 10

Safety and Tolerability: blood test results - creatinine

Creatinine in blood serum, umol/L

Time frame: Screening, Day 10

Safety and Tolerability: blood test results - urea

Urea in blood serum, mmol/L

Time frame: Screening, Day 10

Safety and Tolerability: blood test results - aspartate transaminase (AST)

AST in blood serum, U/L

Time frame: Screening, Day 10

Safety and Tolerability: blood test results - alanine transaminase (ALT)

ALT in blood serum, U/L

Time frame: Screening, Day 10

Safety and Tolerability: blood test results - alkaline phosphatase (ALP)

ALP in blood serum, U/L

Time frame: Screening, Day 10

Safety and Tolerability: urinalysis - specific gravity

Specific gravity of the urine

Time frame: Screening, Day 10

Safety and Tolerability: urinalysis - color

Color of the urine, visual assessment (pale yellow, yellow, amder, brown etc.)

Time frame: Screening, Day 10

Safety and Tolerability: urinalysis - transparency

Transparency of the urine, visual assessment (transparent or cloudy)

Time frame: Screening, Day 10

Safety and Tolerability: urinalysis - pH

pH of the urine

Time frame: Screening, Day 10

Safety and Tolerability: urinalysis - protein

Protein in the urine (g/L)

Time frame: Screening, Day 10

Safety and Tolerability: urinalysis - glucose

Glucose in the urine (mmol/L)

Time frame: Screening, Day 10

Safety and Tolerability: urinalysis (microscopy) - red blood cells

Red blood cells in the urine (number in sight)

Time frame: Screening, Day 10

Safety and Tolerability: urinalysis (microscopy) - white blood cells

White blood cells in the urine (number in sight)

Time frame: Screening, Day 10

Safety and Tolerability: urinalysis (microscopy) - epithelial cells

Epithelial cells in the urine (number in sight)

Time frame: Screening, Day 10

Safety and Tolerability: urinalysis (microscopy) - cylinders

Cylinders in the urine (number in sight)

Time frame: Screening, Day 10

Safety and Tolerability: urinalysis (microscopy) - bacteria

Bacteria in the urine (number in sight)

Time frame: Screening, Day 10

Safety and Tolerability: urinalysis (microscopy) - mucus

Presence of mucus in the urine

Time frame: Screening, Day 10

Safety and Tolerability: adverse event (AE) rate

Number and frequency of adverse events (AEs) or serious AEs (SAEs)

Time frame: From the date of screening (and signing informed consent form) to the end of the study (Day 17)

Safety and Tolerability: local reactions

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)

Time frame: From the date of screening (and signing informed consent form) to the end of the study (Day 17)