Radiation DermatitisNCT03546803
3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis
An observational study of Radiation Dermatitis, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- 3M™ Cavilon™ Advanced Skin Protectant
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2018to 12 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Radiation therapy patients
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of 3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis in Cancer Patients
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
- Being tested
- 3M™ Cavilon™ Advanced Skin Protectant
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M™ Cavilon™ Advanced Skin ProtectantOther
liquid skin protectant on skin to protect from radiation dermatitis
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Head and Neck Patients; Photon or Proton Treatment with product Receives: Other: 3M™ Cavilon™ Advanced Skin Protectant | |
| Cohort B | Hair/skin fold areas (Axilla, Groin, Perineum); Photon or Proton Treatment with product Receives: Other: 3M™ Cavilon™ Advanced Skin Protectant | |
| Cohort C | Misc. (per Rad Onc Physician); Photon or Proton Therapy with routine skin care Receives: Other: 3M™ Cavilon™ Advanced Skin Protectant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months (+/- 1 month) following the completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start19 Feb 2018
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivy A. Petersen, M.D., Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546803
- Sponsor's protocol ID
- 17-006813
- Other IDs
- ROR1603
- Status last verified
- Aug 2019
- First submitted
- 23 May 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of 3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis in Cancer Patients
- ClinicalTrials.gov ID
- NCT03546803
- Acronym / sponsor ID
- 17-006813
- Conditions
- Radiation Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study observes a liquid skin protectant that is a polymeric-cyanoacrylate solution designed to protect intact or damaged skin due to radiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: 3M™ Cavilon™ Advanced Skin ProtectantHead and Neck Patients; Photon or Proton Treatment with product |
| Cohort B | – | Other: 3M™ Cavilon™ Advanced Skin ProtectantHair/skin fold areas (Axilla, Groin, Perineum); Photon or Proton Treatment with product |
| Cohort C | – | Other: 3M™ Cavilon™ Advanced Skin ProtectantMisc. (per Rad Onc Physician); Photon or Proton Therapy with routine skin care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Radiation therapy patients
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3M™ Cavilon™ Advanced Skin Protectantliquid skin protectant on skin to protect from radiation dermatitis | Other | Cohort A, Cohort B, Cohort C |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Dermatitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare radiation dermatitis severity (time frame: 3 months (+/- 1 month) following the completion of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.