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OpenTrials
Completed

NCT Number: NCT03546803

3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis

This study observes a liquid skin protectant that is a polymeric-cyanoacrylate solution designed to protect intact or damaged skin due to radiation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

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

Inclusion criteria

  • Age ≥ 18years.
  • Patient has initial or recurrent disease
  • Undergoing external beam radiotherapy at the Mayo Clinic Rochester campus Note: Patients who are undergoing concurrent chemotherapy are eligible
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Provide informed written consent
  • Willing to consent for photography of radiation field
  • Available to return to Mayo Clinic in within 1 week post treatment for assessment (+/- 7 days).
  • At risk for developing ≥ grade 2 dermatitis radiation as determined by treating Radiation Oncology clinician
  • Biologic effective dose of >42 Gy10 as calculated using the web site EQD2.com.

Exclusion criteria

  • Unable to provide informed consent
  • Patients with active rash, pre-existing dermatitis, lupus or scleroderma within the treatment area that may make skin assessment for the study difficult
  • Known history of developing an allergic reaction after using a product containing cyanoacrylate or acrylates
  • Subject has a medical condition that in the opinion of the investigator should exclude him/her from participating in the study
  • Subject has been enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit
  • The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)

Treatment and study plan

3M™ Cavilon™ Advanced Skin Protectant

Other

liquid skin protectant on skin to protect from radiation dermatitis

Primary outcomes

  1. compare radiation dermatitis severity

    Time frame: 3 months (+/- 1 month) following the completion of radiation therapy

    To compare radiation dermatitis severity in irradiated skin protected by a liquid skin protectant (3M™ Cavilon™ Advanced Skin Protectant) that rapidly dries versus uncovered skin (internal control) as determined by a panel.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Assessment of 3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis in Cancer Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2018
Registry last updated
Aug 14, 2019

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.

Published trials that share one or more normalized conditions with this study.