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OpenTrials
Completed

NCT Number: NCT06276270

Multi-centre, Open-label, First-in-man Study With Mucopad HA

The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results.

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Key information

Conditions

Oral Mucositis Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masarykův onkologický ústav, Klinika radiační onkologie, Brno, Česká Republika, Czechia

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About this study

This is an multi-centre, open-label, first-in-man prospective study.

Up to 60 patients in total will be involved in the open-label trial of new medical device - Mucopad HA. Eligible patients will be undergoing treatment with the device for up to 10 weeks, after which it is expected that there should be significant improvement in the healing process of oral mucositis after radiotherapy. It is considered as an improvement when there is a significant reduction or complete resolution of the mucositis. Mucositis will be assessed as a WHO scale.

Quality of life will be assessed by Oral Mucositis Daily Questionnaire (OMDQ) provided by FACIT. The FACIT and all related works are owned and copyrighted by, and the intellectual property of David Cella, Ph.D. Permission for use of the OMDQ questionnaire is obtained by contacting Dr. Cella at [email protected].

List of investigational sites is in appendix 7.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Oral Mucositis after radiotherapy of grade I - IV according to WHO
  • Patient willing and able to provide the written consent
  • Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study

Exclusion criteria

  • Age < 18 years
  • Pregnant or lactating women
  • Patients in terminal stage of living
  • Patients with known hypersensitivity or allergy to any of the substances contained in Medical Device
  • Alcohol or drug abuse

Treatment and study plan

Mucopad HA

Device

The product is a Class III Medical Device incorporating a medicinal substance (antiseptics-octenidine) within the composition made of sodium hyaluronate polysacharide stabilised by calcium chloride. Device is administered directly onto the area affected by mucositis.

Primary outcomes

  1. Resolution of mucositis symptoms since completion of radiotherapy

    Time frame: 10 weeks

    healing time

Secondary outcomes

  1. - Pain management (VAS scale)

    Time frame: 10 weeks

    pain value 1-100

  2. Development of xerostomy

    Time frame: 10 weeks

    xerostomy yes/no

  3. Subjective evaluation on scale 1-5 of the treatment by investigator/ patient

    Time frame: 10 weeks

    scale 1-5

Sponsors and collaborators

Lead sponsor

Contipro Pharma a.s.

Other

Registry information

Official study title

Multi-centre, Open-label, First-in-man Study With Mucopad HA Used in Adult Patients Suffered From Oral Mucositis After Radiotherapy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 23, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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