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PyodermaPhase 3NCT05561816

Efficacy and Safety of Dioxidin Versus Miramistin in Superficial Pyoderma

A Phase 3 study testing Hydroxymethylquinoxalindioxyde and Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium in people with Pyoderma, run by Valenta Pharm JSC at 10 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pyoderma
What is being tested?
Hydroxymethylquinoxalindioxyde and Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
10 sitesRussia
Study dates
19 Jul 2022to 20 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 38Show fewer
  • 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.
  • 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).
  • 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.
  • 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).
  • The need for concomitant therapy with any of the drugs listed as "Prohibited Concomitant Treatment".
  • History of alcohol and/or drug dependence.
  • Participation in another clinical trial less than 3 months prior to the Screening Visit.
  • Pregnancy.
  • Breastfeeding period.
  • Withdrawal Criteria:
  • Withdrawal of Informed Consent by the patient.
  • Patient does not meet inclusion criteria.
  • Patient is found to have non-inclusion criteria.
  • Patient's desire to stop their participation in the study at any stage of the study.
  • Researcher's decision that continued participation in the study is contrary to the patient's best interests.
  • The investigator's decision to exclude the patient from the study due to a serious deviation from/breach of protocol.
  • Identification of a probable or confirmed COVID- 19 case (according to the Standard COVID-19 case definition).
  • An undesirable event requiring withdrawal of study therapy, or prescription of drugs from the Prohibited Complementary Treatment section, or limiting protocol procedures.
  • Patient's failure to show up for any visit and loss of communication with the patient.
  • Patient's omission of a cumulative total of more than 5 doses of medication throughout the treatment period or 3 consecutive doses.
  • Pregnancy.
  • Termination of the study by the sponsor.
  • Termination of the study by the investigator.
  • Termination of the study by the regulatory agency.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Russia10 sites

  • Chelyabinsk Regional Clinical Dermatology and Venereology Dispensary

    Chelyabinsk

  • Professor Gorbakov Clinic, LLC

    Krasnogorsk

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

    Moscow

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

    Ryazan

  • Regional Clinical Dermatology and Venereology Dispensary

    Ryazan

  • City Dermatological and Venereological Dispensary

    Saint Petersburg

  • Northwestern Center for Evidence-based Medicine, JSC

    Saint Petersburg

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

    Saint Petersburg

  • Yakusi Clinic, LLC

    Saint Petersburg

  • Clinic of Modern Medicine of Dr. Bogorodskaya, LLC

    Yaroslavl

Other trials in Russia

About this study

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

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
Being tested
Hydroxymethylquinoxalindioxyde, Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium
Medical subject headings
Pyoderma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydroxymethylquinoxalindioxydeDrug

    Also called Dioxidin

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

  • Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azaniumDrug

    Also called Miramistin

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

Study groups in NCT05561816
Study groupRoleWhat they receive
DioxidinExperimentalPatients 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.
Receives: Drug: Hydroxymethylquinoxalindioxyde
MiramistinActive comparatorPatients 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.
Receives: Drug: Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium

What is being measured

The primary outcome is the main question the study is designed to answer.

  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])

    Measured: Day 10

Secondary outcomes (46)

  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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: Day 4, Day 7, Day 10

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

    SBP, mmHg

    Measured: Screening, Day 1, Day 4, Day 7, Day 10

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

    DBP, mmHg

    Measured: Screening, Day 1, Day 4, Day 7, Day 10

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

    HR, beats per minute

    Measured: Screening, Day 1, Day 4, Day 7, Day 10

  11. Safety and Tolerability: vital signs - body temperature

    Body temperature, centigrade scale

    Measured: 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.

    Measured: Screening, Day 1, Day 4, Day 7, Day 10

  13. Safety and Tolerability: complete blood count - hemoglobin

    Hemoglobin, g/dL

    Measured: Screening, Day 10

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

    Red blood cells, 10^6/uL

    Measured: Screening, Day 10

  15. Safety and Tolerability: complete blood count - hematocrit

    Hematocrit, %

    Measured: Screening, Day 10

  16. Safety and Tolerability: complete blood count - platelets

    Platelets, 10^3/uL

    Measured: Screening, Day 10

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

    White blood cells, 10^3/uL

    Measured: Screening, Day 10

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

    Erythrocyte sedimentation rate, mm per hour

    Measured: Screening, Day 10

  19. Safety and Tolerability: complete blood count - lymphocytes

    Lymphocytes, %

    Measured: Screening, Day 10

  20. Safety and Tolerability: complete blood count - eosinophils

    Eosinophils, %

    Measured: Screening, Day 10

  21. Safety and Tolerability: complete blood count - monocytes

    Monocytes, %

    Measured: Screening, Day 10

  22. Safety and Tolerability: complete blood count - basophils

    Basophils, %

    Measured: Screening, Day 10

  23. Safety and Tolerability: complete blood count - neutrophils

    Neutrophils, % (segmented and stab)

    Measured: Screening, Day 10

  24. Safety and Tolerability: blood test results - glucose

    Glucose in blood serum, mmol/L

    Measured: Screening, Day 10

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

    Total cholesterol in blood serum, mmol/L

    Measured: Screening, Day 10

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

    Total bilirubin in blood serum, umol/L

    Measured: Screening, Day 10

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

    Total protein in blood serum, g/L

    Measured: Screening, Day 10

  28. Safety and Tolerability: blood test results - creatinine

    Creatinine in blood serum, umol/L

    Measured: Screening, Day 10

  29. Safety and Tolerability: blood test results - urea

    Urea in blood serum, mmol/L

    Measured: Screening, Day 10

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

    AST in blood serum, U/L

    Measured: Screening, Day 10

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

    ALT in blood serum, U/L

    Measured: Screening, Day 10

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

    ALP in blood serum, U/L

    Measured: Screening, Day 10

  33. Safety and Tolerability: urinalysis - specific gravity

    Specific gravity of the urine

    Measured: Screening, Day 10

  34. Safety and Tolerability: urinalysis - color

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

    Measured: Screening, Day 10

  35. Safety and Tolerability: urinalysis - transparency

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

    Measured: Screening, Day 10

  36. Safety and Tolerability: urinalysis - pH

    pH of the urine

    Measured: Screening, Day 10

  37. Safety and Tolerability: urinalysis - protein

    Protein in the urine (g/L)

    Measured: Screening, Day 10

  38. Safety and Tolerability: urinalysis - glucose

    Glucose in the urine (mmol/L)

    Measured: Screening, Day 10

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

    Red blood cells in the urine (number in sight)

    Measured: Screening, Day 10

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

    White blood cells in the urine (number in sight)

    Measured: Screening, Day 10

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

    Epithelial cells in the urine (number in sight)

    Measured: Screening, Day 10

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

    Cylinders in the urine (number in sight)

    Measured: Screening, Day 10

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

    Bacteria in the urine (number in sight)

    Measured: Screening, Day 10

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

    Presence of mucus in the urine

    Measured: Screening, Day 10

  45. Safety and Tolerability: adverse event (AE) rate

    Number and frequency of adverse events (AEs) or serious AEs (SAEs)

    Measured: 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)

    Measured: From the date of screening (and signing informed consent form) to the end of the study (Day 17)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2022
  2. Study start19 Jul 2022
  3. Primary completion28 Nov 2022
  4. Study completion20 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05561816
Sponsor's protocol ID
DIO-09-2020
Status last verified
Oct 2023
First submitted
15 Sep 2022
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydroxymethylquinoxalindioxyde and Benzyl-dimethyl-[3-(tetradecanoylamino)propyl]azanium in people with Pyoderma, run by Valenta Pharm JSC at 10 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who experienced complete cure of the disease at Visit 4 (time frame: Day 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05561816.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.

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