Clinical trial NCT05561816: Efficacy and Safety of Dioxidin Versus Miramistin in Superficial Pyoderma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pyoderma
Lead sponsor: Valenta Pharm JSC
Sponsor class: INDUSTRY
First posted: 2022-09-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients who experienced complete cure of the disease at Visit 4
timeFrame: Day 10
Secondary outcomes:
measure: Mean change in the arithmetic mean change in pyoderma symptom severity scale, to Visits 2, 3, and 4 compared to baseline.
timeFrame: Day 1, Day 4, Day 7, Day 10
measure: Mean change in severity for the symptom "soreness on palpation" to Visits 2, 3 and 4 compared to baseline
timeFrame: Day 1, Day 4, Day 7, Day 10
measure: Average change in the severity for the symptom "presence of pustules/flukteness" to Visits 2, 3 and 4 compared to baseline
timeFrame: Day 1, Day 4, Day 7, Day 10
measure: Average change in the expression for the symptom "hyperemia" to Visits 2, 3 and 4 compared to baseline
timeFrame: Day 1, Day 4, Day 7, Day 10
measure: Mean change in severity for the symptom "inflammatory infiltration" to Visits 2, 3 and 4 compared to baseline
timeFrame: Day 1, Day 4, Day 7, Day 10
measure: Mean change in severity for the symptom "swelling" to Visits 2, 3 and 4 compared to baseline
timeFrame: Day 1, Day 4, Day 7, Day 10
measure: Average patient satisfaction with treatment at Visit 2, 3 and 4
timeFrame: Day 4, Day 7, Day 10
measure: Safety and Tolerability: vital signs - systolic blood pressure (SBP)
timeFrame: Screening, Day 1, Day 4, Day 7, Day 10
measure: Safety and Tolerability: vital signs - diastolic blood pressure (DBP)
timeFrame: Screening, Day 1, Day 4, Day 7, Day 10
measure: Safety and Tolerability: vital signs - heart rate (HR)
timeFrame: Screening, Day 1, Day 4, Day 7, Day 10
measure: Safety and Tolerability: vital signs - body temperature
timeFrame: Screening, Day 1, Day 4, Day 7, Day 10
measure: Safety and Tolerability: physical examination results
timeFrame: Screening, Day 1, Day 4, Day 7, Day 10
measure: Safety and Tolerability: complete blood count - hemoglobin
timeFrame: Screening, Day 10
measure: Safety and Tolerability: complete blood count - red blood cells
timeFrame: Screening, Day 10
measure: Safety and Tolerability: complete blood count - hematocrit
timeFrame: Screening, Day 10
measure: Safety and Tolerability: complete blood count - platelets
timeFrame: Screening, Day 10
measure: Safety and Tolerability: complete blood count - white blood cells
timeFrame: Screening, Day 10
measure: Safety and Tolerability: complete blood count - erythrocyte sedimentation rate
timeFrame: Screening, Day 10
measure: Safety and Tolerability: complete blood count - lymphocytes
timeFrame: Screening, Day 10
measure: Safety and Tolerability: complete blood count - eosinophils
timeFrame: Screening, Day 10
measure: Safety and Tolerability: complete blood count - monocytes
timeFrame: Screening, Day 10
measure: Safety and Tolerability: complete blood count - basophils
timeFrame: Screening, Day 10
measure: Safety and Tolerability: complete blood count - neutrophils
timeFrame: Screening, Day 10
measure: Safety and Tolerability: blood test results - glucose
timeFrame: Screening, Day 10
measure: Safety and Tolerability: blood test results - total cholesterol
timeFrame: Screening, Day 10
measure: Safety and Tolerability: blood test results - total bilirubin
timeFrame: Screening, Day 10
measure: Safety and Tolerability: blood test results - total protein
timeFrame: Screening, Day 10
measure: Safety and Tolerability: blood test results - creatinine
timeFrame: Screening, Day 10
measure: Safety and Tolerability: blood test results - urea
timeFrame: Screening, Day 10
measure: Safety and Tolerability: blood test results - aspartate transaminase (AST)
timeFrame: Screening, Day 10
measure: Safety and Tolerability: blood test results - alanine transaminase (ALT)
timeFrame: Screening, Day 10
measure: Safety and Tolerability: blood test results - alkaline phosphatase (ALP)
timeFrame: Screening, Day 10
measure: Safety and Tolerability: urinalysis - specific gravity
timeFrame: Screening, Day 10
measure: Safety and Tolerability: urinalysis - color
timeFrame: Screening, Day 10
measure: Safety and Tolerability: urinalysis - transparency
timeFrame: Screening, Day 10
measure: Safety and Tolerability: urinalysis - pH
timeFrame: Screening, Day 10
measure: Safety and Tolerability: urinalysis - protein
timeFrame: Screening, Day 10
measure: Safety and Tolerability: urinalysis - glucose
timeFrame: Screening, Day 10
measure: Safety and Tolerability: urinalysis (microscopy) - red blood cells
timeFrame: Screening, Day 10
measure: Safety and Tolerability: urinalysis (microscopy) - white blood cells
timeFrame: Screening, Day 10
measure: Safety and Tolerability: urinalysis (microscopy) - epithelial cells
timeFrame: Screening, Day 10
measure: Safety and Tolerability: urinalysis (microscopy) - cylinders
timeFrame: Screening, Day 10
measure: Safety and Tolerability: urinalysis (microscopy) - bacteria
timeFrame: Screening, Day 10
measure: Safety and Tolerability: urinalysis (microscopy) - mucus
timeFrame: Screening, Day 10
measure: Safety and Tolerability: adverse event (AE) rate
timeFrame: From the date of screening (and signing informed consent form) to the end of the study (Day 17)
measure: Safety and Tolerability: local reactions
timeFrame: From the date of screening (and signing informed consent form) to the end of the study (Day 17)
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Dermatology and Venereology Dispensary
city: Krasnogorsk
country: Russian Federation
facility: Professor Gorbakov Clinic, LLC
city: Moscow
country: Russian Federation
facility: Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology of the Moscow Department of Health
city: Ryazan'
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Professional Education Ryazan State Medical University, Ministry of Health of Russia
city: Ryazan'
country: Russian Federation
facility: Regional Clinical Dermatology and Venereology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: City Dermatological and Venereological Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Northwestern Center for Evidence-based Medicine, JSC
city: Saint Petersburg
country: Russian Federation
facility: Private Health Care Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg
city: Saint Petersburg
country: Russian Federation
facility: Yakusi Clinic, LLC
city: Yaroslavl
country: Russian Federation
facility: Clinic of Modern Medicine of Dr. Bogorodskaya, LLC
Study officials:
References: