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

August 12, 2019 updated by: Ivy A. Petersen, M.D., Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Radiation therapy patients

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort A
Head and Neck Patients; Photon or Proton Treatment with product
Other: 3M™ Cavilon™ Advanced Skin Protectant
liquid skin protectant on skin to protect from radiation dermatitis
Cohort B
Hair/skin fold areas (Axilla, Groin, Perineum); Photon or Proton Treatment with product
Other: 3M™ Cavilon™ Advanced Skin Protectant
liquid skin protectant on skin to protect from radiation dermatitis
Cohort C
Misc. (per Rad Onc Physician); Photon or Proton Therapy with routine skin care
Other: 3M™ Cavilon™ Advanced Skin Protectant
liquid skin protectant on skin to protect from radiation dermatitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months (+/- 1 month) following the completion of radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2018

Primary Completion (Actual)

August 12, 2019

Study Completion (Actual)

August 12, 2019

Study Registration Dates

First Submitted

May 23, 2018

First Submitted That Met QC Criteria

May 23, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-006813
  • ROR1603 (Other Identifier: Mayo Clinic)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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