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

NCT03546803 | Completed

• 2 other identifiers: 17-006813ROR1603
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• compare radiation dermatitis severity

  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

Study Arms (3)

Cohort A

Head and Neck Patients; Photon or Proton Treatment with product

Other: 3M™ Cavilon™ Advanced Skin Protectant

Cohort B

Hair/skin fold areas (Axilla, Groin, Perineum); Photon or Proton Treatment with product

Other: 3M™ Cavilon™ Advanced Skin Protectant

Cohort C

Misc. (per Rad Onc Physician); Photon or Proton Therapy with routine skin care

Other: 3M™ Cavilon™ Advanced Skin Protectant

Interventions

3M™ Cavilon™ Advanced Skin Protectant OTHER

liquid skin protectant on skin to protect from radiation dermatitis

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Radiation therapy patients

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncology Consultant

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: February 19, 2018
• Primary Completion: August 12, 2019
• Study Completion: August 12, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

US (1)