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CompletedNCT05561816Updated Oct 10, 2023

Efficacy and Safety of Dioxidin Versus Miramistin in Superficial Pyoderma

A Phase 3 interventional study of Hydroxymethylquinoxalindioxyde and Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium in Pyoderma, sponsored by Valenta Pharm JSC. Completed at 10 sites in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Valenta Pharm JSC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Pyoderma

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03

In context

Pyoderma

11 studies on the registry are indexed under Pyoderma; 2 are open to participants now.

Browse Pyoderma studies →

Lead sponsor

Valenta Pharm JSC is the lead sponsor of 40 studies on the registry; 18 are open to participants now.

Browse Valenta Pharm JSC studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Men and women between the ages of 18 and 65 years inclusive.
  2. Signed 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 to use adequate methods of (e.g., dual barrier method) throughout the study and for 3 weeks after study completion.

Exclusion criteria

Exclusion Criteria:

  1. to the active and/or 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 , 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 , 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 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    Dioxidin

    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

  • Active comparator
    Miramistin

    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

  • DrugHydroxymethylquinoxalindioxyde

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

    Also known as: Dioxidin

  • DrugBenzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium

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

    Also known as: Miramistin

06

What researchers measure

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 \[maximal severity of the symptom\])

    Time frame: Day 10

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

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

  6. 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

  7. 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

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

    SBP, mmHg

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

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

    DBP, mmHg

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

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

    HR, beats per minute

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

  11. Safety and Tolerability: vital signs - body temperature

    Body temperature, centigrade scale

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

  12. 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

  13. Safety and Tolerability: complete blood count - hemoglobin

    Hemoglobin, g/dL

    Time frame: Screening, Day 10

  14. Safety and Tolerability: complete blood count - red blood cells

    Red blood cells, 10\^6/uL

    Time frame: Screening, Day 10

  15. Safety and Tolerability: complete blood count - hematocrit

    Hematocrit, %

    Time frame: Screening, Day 10

  16. Safety and Tolerability: complete blood count - platelets

    Platelets, 10\^3/uL

    Time frame: Screening, Day 10

  17. Safety and Tolerability: complete blood count - white blood cells

    White blood cells, 10\^3/uL

    Time frame: Screening, Day 10

  18. Safety and Tolerability: complete blood count - erythrocyte sedimentation rate

    Erythrocyte sedimentation rate, mm per hour

    Time frame: Screening, Day 10

  19. Safety and Tolerability: complete blood count - lymphocytes

    Lymphocytes, %

    Time frame: Screening, Day 10

  20. Safety and Tolerability: complete blood count - eosinophils

    Eosinophils, %

    Time frame: Screening, Day 10

  21. Safety and Tolerability: complete blood count - monocytes

    Monocytes, %

    Time frame: Screening, Day 10

  22. Safety and Tolerability: complete blood count - basophils

    Basophils, %

    Time frame: Screening, Day 10

  23. Safety and Tolerability: complete blood count - neutrophils

    Neutrophils, % (segmented and stab)

    Time frame: Screening, Day 10

  24. Safety and Tolerability: blood test results - glucose

    Glucose in blood serum, mmol/L

    Time frame: Screening, Day 10

  25. Safety and Tolerability: blood test results - total cholesterol

    Total cholesterol in blood serum, mmol/L

    Time frame: Screening, Day 10

  26. Safety and Tolerability: blood test results - total bilirubin

    Total bilirubin in blood serum, umol/L

    Time frame: Screening, Day 10

  27. Safety and Tolerability: blood test results - total protein

    Total protein in blood serum, g/L

    Time frame: Screening, Day 10

  28. Safety and Tolerability: blood test results - creatinine

    Creatinine in blood serum, umol/L

    Time frame: Screening, Day 10

  29. Safety and Tolerability: blood test results - urea

    Urea in blood serum, mmol/L

    Time frame: Screening, Day 10

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

    AST in blood serum, U/L

    Time frame: Screening, Day 10

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

    ALT in blood serum, U/L

    Time frame: Screening, Day 10

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

    ALP in blood serum, U/L

    Time frame: Screening, Day 10

  33. Safety and Tolerability: urinalysis - specific gravity

    Specific gravity of the urine

    Time frame: Screening, Day 10

  34. Safety and Tolerability: urinalysis - color

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

    Time frame: Screening, Day 10

  35. Safety and Tolerability: urinalysis - transparency

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

    Time frame: Screening, Day 10

  36. Safety and Tolerability: urinalysis - pH

    pH of the urine

    Time frame: Screening, Day 10

  37. Safety and Tolerability: urinalysis - protein

    Protein in the urine (g/L)

    Time frame: Screening, Day 10

  38. Safety and Tolerability: urinalysis - glucose

    Glucose in the urine (mmol/L)

    Time frame: Screening, Day 10

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

    Red blood cells in the urine (number in sight)

    Time frame: Screening, Day 10

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

    White blood cells in the urine (number in sight)

    Time frame: Screening, Day 10

  41. Safety and Tolerability: urinalysis (microscopy) - epithelial cells

    Epithelial cells in the urine (number in sight)

    Time frame: Screening, Day 10

  42. Safety and Tolerability: urinalysis (microscopy) - cylinders

    Cylinders in the urine (number in sight)

    Time frame: Screening, Day 10

  43. Safety and Tolerability: urinalysis (microscopy) - bacteria

    Bacteria in the urine (number in sight)

    Time frame: Screening, Day 10

  44. Safety and Tolerability: urinalysis (microscopy) - mucus

    Presence of mucus in the urine

    Time frame: Screening, Day 10

  45. 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)

  46. 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)

07

Study locations

10 sites
  • 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, Russian Federation
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2022 to primary completion in Nov 2022, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2022
First posted
Sep 30, 2022
StartActual
Jul 19, 2022
Primary completionActual
Nov 28, 2022
CompletionActual
Dec 20, 2022
Last update
Oct 10, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05561816
Lead sponsor
Valenta Pharm JSC
Responsible party
Sponsor
First posted
Sep 30, 2022
Start date
Jul 19, 2022
Primary completion
Nov 28, 2022
Completion
Dec 20, 2022
Last update
Oct 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Dioxidine

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