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Trial record 6 of 1998 for:    "Mayo Clinic" [Exact]

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

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ClinicalTrials.gov Identifier: NCT03546803
Recruitment Status : Recruiting
First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ivy A. Petersen, M.D., Mayo Clinic

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

Condition or disease Intervention/treatment
Radiation Dermatitis Other: 3M™ Cavilon™ Advanced Skin Protectant

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of 3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis in Cancer Patients
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Radiation therapy patients
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546803


Contacts
Contact: Clinical Trials Referral Office 5073283000

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Julie Simonson         
Sponsors and Collaborators
Mayo Clinic

Responsible Party: Ivy A. Petersen, M.D., Radiation Oncology Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03546803     History of Changes
Other Study ID Numbers: 17-006813
ROR1603 ( Other Identifier: Mayo Clinic )
First Posted: June 5, 2018    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis
Radiodermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries
Protective Agents
Physiological Effects of Drugs