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

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Mayo Clinic

Status

Completed

Conditions

Radiation Dermatitis

Treatments

Other: 3M™ Cavilon™ Advanced Skin Protectant

Study type

Observational

Funder types

Other

Identifiers

NCT03546803
ROR1603 (Other Identifier)
17-006813

Details and patient eligibility

About

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

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

14 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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