Efficacy and Safety of Dioxidin Versus Miramistin in Superficial Pyoderma

NCT05561816 | Completed Phase 3

• 1 other identifier: DIO-09-2020
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 10

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.

Conditions

Pyoderma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (46)

• 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

• 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

• 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 "inflammatory infiltration" to Visits 2, 3 and 4 compared to baseline

  Day 1, Day 4, Day 7, Day 10

Study Arms (2)

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.

Drug: Hydroxymethylquinoxalindioxyde

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.

Drug: Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium

Interventions

Hydroxymethylquinoxalindioxyde DRUG

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

Also known as: Dioxidin

Dioxidin

Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium DRUG

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

Also known as: Miramistin

Miramistin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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-19.
• 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 2.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (10)

Chelyabinsk Regional Clinical Dermatology and Venereology Dispensary

Chelyabinsk, Russia

Location

Professor Gorbakov Clinic, LLC

Krasnogorsk, Russia

Location

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

Moscow, Russia

Location

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

Ryazan, Russia

Location

Regional Clinical Dermatology and Venereology Dispensary

Ryazan, Russia

Location

City Dermatological and Venereological Dispensary

Saint Petersburg, Russia

Location

Northwestern Center for Evidence-based Medicine, JSC

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

Yakusi Clinic, LLC

Saint Petersburg, Russia

Location

Clinic of Modern Medicine of Dr. Bogorodskaya, LLC

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Pyoderma

Interventions

miramistin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 30, 2022
• Study Start: July 19, 2022
• Primary Completion: November 28, 2022
• Study Completion: December 20, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

RU (10)