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

Completed

• Conditions: Radiation Dermatitis
• Interventions: Other: 3M™ Cavilon™ Advanced Skin Protectant

• Registration Number: NCT03546803
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-19
• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-05-23
• Study First Posted: 2018-06-06
• Status Verified: 2019-08
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
compare radiation dermatitis severity	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States