Efficacy and Safety of Dioxidin Versus Miramistin in Superficial Pyoderma

Valenta Pharm

Status and phase: Completed; Phase 3

Conditions: Pyoderma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05561816

DIO-09-2020

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Dioxidin

Experimental group

Description:

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.

Treatment:

Drug: Hydroxymethylquinoxalindioxyde

Miramistin

Active Comparator group

Description:

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.

Treatment:

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