Efficacy and Safety of Dioxidin Versus Miramistin in Superficial Pyoderma

Pyoderma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05561816
• Other study ID #: DIO-09-2020
• Status: Completed
• Phase: Phase 3
• Start date: July 19, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: October 2023
• Source: Valenta Pharm JSC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 20, 2022
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pyoderma

Intervention

Drug:
• Hydroxymethylquinoxalindioxyde
Dioxidin®, 0.025% solution for local and external use (Valenta Farm, Russia).
• Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium
Miramistin®, topical solution 0.01% (Infamed K LLC, Russia)

Locations

Country	Name	City	State
Russian Federation	Chelyabinsk Regional Clinical Dermatology and Venereology Dispensary	Chelyabinsk
Russian Federation	Professor Gorbakov Clinic, LLC	Krasnogorsk
Russian Federation	Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology of the Moscow Department of Health	Moscow
Russian Federation	Federal State Budgetary Educational Institution of Higher Professional Education Ryazan State Medical University, Ministry of Health of Russia	Ryazan'
Russian Federation	Regional Clinical Dermatology and Venereology Dispensary	Ryazan'
Russian Federation	City Dermatological and Venereological Dispensary	Saint Petersburg
Russian Federation	Northwestern Center for Evidence-based Medicine, JSC	Saint Petersburg
Russian Federation	Private Health Care Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg	Saint Petersburg
Russian Federation	Yakusi Clinic, LLC	Saint Petersburg
Russian Federation	Clinic of Modern Medicine of Dr. Bogorodskaya, LLC	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Valenta Pharm JSC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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])	Day 10
Secondary	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)	Day 1, Day 4, Day 7, Day 10
Secondary	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)	Day 1, Day 4, Day 7, Day 10
Secondary	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)	Day 1, Day 4, Day 7, Day 10
Secondary	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)	Day 1, Day 4, Day 7, Day 10
Secondary	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)	Day 1, Day 4, Day 7, Day 10
Secondary	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)	Day 1, Day 4, Day 7, Day 10
Secondary	Average patient satisfaction with treatment at Visit 2, 3 and 4	The satisfaction will be assessed from 0 (not satisfied) to 3 (absolutely satisfied)	Day 4, Day 7, Day 10
Secondary	Safety and Tolerability: vital signs - systolic blood pressure (SBP)	SBP, mmHg	Screening, Day 1, Day 4, Day 7, Day 10
Secondary	Safety and Tolerability: vital signs - diastolic blood pressure (DBP)	DBP, mmHg	Screening, Day 1, Day 4, Day 7, Day 10
Secondary	Safety and Tolerability: vital signs - heart rate (HR)	HR, beats per minute	Screening, Day 1, Day 4, Day 7, Day 10
Secondary	Safety and Tolerability: vital signs - body temperature	Body temperature, centigrade scale	Screening, Day 1, Day 4, Day 7, Day 10
Secondary	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.	Screening, Day 1, Day 4, Day 7, Day 10
Secondary	Safety and Tolerability: complete blood count - hemoglobin	Hemoglobin, g/dL	Screening, Day 10
Secondary	Safety and Tolerability: complete blood count - red blood cells	Red blood cells, 10^6/uL	Screening, Day 10
Secondary	Safety and Tolerability: complete blood count - hematocrit	Hematocrit, %	Screening, Day 10
Secondary	Safety and Tolerability: complete blood count - platelets	Platelets, 10^3/uL	Screening, Day 10
Secondary	Safety and Tolerability: complete blood count - white blood cells	White blood cells, 10^3/uL	Screening, Day 10
Secondary	Safety and Tolerability: complete blood count - erythrocyte sedimentation rate	Erythrocyte sedimentation rate, mm per hour	Screening, Day 10
Secondary	Safety and Tolerability: complete blood count - lymphocytes	Lymphocytes, %	Screening, Day 10
Secondary	Safety and Tolerability: complete blood count - eosinophils	Eosinophils, %	Screening, Day 10
Secondary	Safety and Tolerability: complete blood count - monocytes	Monocytes, %	Screening, Day 10
Secondary	Safety and Tolerability: complete blood count - basophils	Basophils, %	Screening, Day 10
Secondary	Safety and Tolerability: complete blood count - neutrophils	Neutrophils, % (segmented and stab)	Screening, Day 10
Secondary	Safety and Tolerability: blood test results - glucose	Glucose in blood serum, mmol/L	Screening, Day 10
Secondary	Safety and Tolerability: blood test results - total cholesterol	Total cholesterol in blood serum, mmol/L	Screening, Day 10
Secondary	Safety and Tolerability: blood test results - total bilirubin	Total bilirubin in blood serum, umol/L	Screening, Day 10
Secondary	Safety and Tolerability: blood test results - total protein	Total protein in blood serum, g/L	Screening, Day 10
Secondary	Safety and Tolerability: blood test results - creatinine	Creatinine in blood serum, umol/L	Screening, Day 10
Secondary	Safety and Tolerability: blood test results - urea	Urea in blood serum, mmol/L	Screening, Day 10
Secondary	Safety and Tolerability: blood test results - aspartate transaminase (AST)	AST in blood serum, U/L	Screening, Day 10
Secondary	Safety and Tolerability: blood test results - alanine transaminase (ALT)	ALT in blood serum, U/L	Screening, Day 10
Secondary	Safety and Tolerability: blood test results - alkaline phosphatase (ALP)	ALP in blood serum, U/L	Screening, Day 10
Secondary	Safety and Tolerability: urinalysis - specific gravity	Specific gravity of the urine	Screening, Day 10
Secondary	Safety and Tolerability: urinalysis - color	Color of the urine, visual assessment (pale yellow, yellow, amder, brown etc.)	Screening, Day 10
Secondary	Safety and Tolerability: urinalysis - transparency	Transparency of the urine, visual assessment (transparent or cloudy)	Screening, Day 10
Secondary	Safety and Tolerability: urinalysis - pH	pH of the urine	Screening, Day 10
Secondary	Safety and Tolerability: urinalysis - protein	Protein in the urine (g/L)	Screening, Day 10
Secondary	Safety and Tolerability: urinalysis - glucose	Glucose in the urine (mmol/L)	Screening, Day 10
Secondary	Safety and Tolerability: urinalysis (microscopy) - red blood cells	Red blood cells in the urine (number in sight)	Screening, Day 10
Secondary	Safety and Tolerability: urinalysis (microscopy) - white blood cells	White blood cells in the urine (number in sight)	Screening, Day 10
Secondary	Safety and Tolerability: urinalysis (microscopy) - epithelial cells	Epithelial cells in the urine (number in sight)	Screening, Day 10
Secondary	Safety and Tolerability: urinalysis (microscopy) - cylinders	Cylinders in the urine (number in sight)	Screening, Day 10
Secondary	Safety and Tolerability: urinalysis (microscopy) - bacteria	Bacteria in the urine (number in sight)	Screening, Day 10
Secondary	Safety and Tolerability: urinalysis (microscopy) - mucus	Presence of mucus in the urine	Screening, Day 10
Secondary	Safety and Tolerability: adverse event (AE) rate	Number and frequency of adverse events (AEs) or serious AEs (SAEs)	From the date of screening (and signing informed consent form) to the end of the study (Day 17)
Secondary	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)	From the date of screening (and signing informed consent form) to the end of the study (Day 17)