CompletedNCT03546803Updated Aug 14, 2019

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

An observational study in Radiation Dermatitis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-14.

Sponsored by Mayo Clinic · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 14
Ages: 18 Years and older
Sex: All

Study 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 studied

Radiation Dermatitis

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In context

Dermatitis

1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.

This study's enrollment of 14 is below the median of 100 across 232 observational studies indexed under Dermatitis.

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Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 669 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Sampling method: Non-probability sample

Study population

Radiation therapy patients

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

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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 14 participants (actual)
Patient registry: No

Groups and cohorts

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

Other3M™ Cavilon™ Advanced Skin Protectant
liquid skin protectant on skin to protect from radiation dermatitis

What researchers measure

Primary outcomes

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.
Time frame: 3 months (+/- 1 month) following the completion of radiation therapy

Study locations

1 site

Mayo Clinic
Rochester, Minnesota 55905, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03546803
Lead sponsor: Mayo Clinic
Responsible party: Ivy A. Petersen, M.D. (Radiation Oncology Consultant, Mayo Clinic) — Principal investigator
First posted: Jun 6, 2018
Start date: Feb 19, 2018
Primary completion: Aug 12, 2019
Completion: Aug 12, 2019
Last update: Aug 14, 2019

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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