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

Radiation Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546803
• Other study ID #: 17-006813
• Secondary ID: ROR1603
• Status: Completed
• Start date: February 19, 2018
• Est. completion date: August 12, 2019

Study information

• Verified date: August 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 12, 2019
• Est. primary completion date: August 12, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

Other:
• 3M™ Cavilon™ Advanced Skin Protectant
liquid skin protectant on skin to protect from radiation dermatitis

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials