RadiodermatitisPhase 1/2NCT02534129
Topical Use of Difinsa53™ to Prevent Radiation Dermatitis
A Phase 1/2 study testing Difinsa53 and Aquaphor in people with Radiodermatitis, run by ProTechSure Scientific, Inc. at 1 site in United States.
Trial summary
Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Radiodermatitis
- What is being tested?
- Difinsa53 and Aquaphor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Mar 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female patients 18 years and older
- Pathologic diagnosis of breast cancer requiring radiation therapy to whole breast
- Able to apply lotion to treatment area at least twice daily during radiation course
- All surgical sites healed
- No evidence of infection
- No history of sensitivity to any component in Aquaphor or Difensa53
Who cannot join
- Prior history of radiation therapy (RT) to that site
- Known dermatologic conditions affecting skin in radiation port
- Concurrent chemotherapy
- Skin infection in radiation port
- History of sensitivity to Aquaphor or Difensa53 component
Trial locations and contacts
1 site in 1 country.
United States1 site
Poudre Valley Health System
Fort Collins, Colorado, 80528
About this study
Official title: Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer: A Prospective Study
Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.
Read the detailed description
The proposed study seeks to evaluate the efficacy of DIFINISA53™, a safe silibin-based skin cream, on preventing radiation dermatitis (RD) when compared to an over the counter ointment, Aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or mastectomy surgery. Presently there is no known fully effective topical protectant from RD and there is no consensus among radiation oncologists on how best to treat RD. This study seeks to identify a more effective option for patients receiving radiation therapy. Each participant will apply the DIFINISA53™ cream to one area of the treated skin and Aquaphor to another area of treated skin. Skin reactions will be evaluated using medical professional assessment, participant assessment, and photographic assessment by a third party.
- Conditions
- Radiodermatitis
- Being tested
- Difinsa53, Aquaphor
- Keywords
- breast cancer, radiation, dermatitis
- Medical subject headings
- Radiodermatitis, Breast Neoplasms, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difinsa53Drug
Also called Dimethicone
Difinsa53 cream is applied to one half of radiation field
AquaphorDrug
Also called petrolatum
Aquaphor is applied to one half of radiation field
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor Receives: Drug: Difinsa53; Drug: Aquaphor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria
A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Insufficient dermatitis was seen in the controls to allow any determination of protection by Difinsa53
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RadiodermatitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProTechSure Scientific, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Poudre Valley Health System
- Responsible party
- Sponsor
- Investigators
- Joshua Petit, MD, Principal investigator, UC Health, Poudre Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534129
- Sponsor's protocol ID
- ProTechSure 001
- Status last verified
- Oct 2017
- First submitted
- 19 Aug 2015
- Last updated
- 6 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McQuestion M. Evidence-based skin care management in radiation therapy: clinical update. Semin Oncol Nurs. 2011 May;27(2):e1-17. doi: 10.1016/j.soncn.2011.02.009.
PubMed 21514477Becker-Schiebe M, Mengs U, Schaefer M, Bulitta M, Hoffmann W. Topical use of a silymarin-based preparation to prevent radiodermatitis : results of a prospective study in breast cancer patients. Strahlenther Onkol. 2011 Aug;187(8):485-91. doi: 10.1007/s00066-011-2204-z. Epub 2011 Jul 22.
PubMed 21786113
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer: A Prospective Study
- ClinicalTrials.gov ID
- NCT02534129
- Acronym / sponsor ID
- ProTechSure 001
- Conditions
- Radiodermatitis
- Keywords
- breast cancer, radiation, dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient dermatitis was seen in the controls to allow any determination of protection by Difinsa53
- Enrolment
- 13 participants (actual)
- Lead sponsor
- ProTechSure Scientific, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Poudre Valley Health System
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Posted 6 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.
Detailed description
The proposed study seeks to evaluate the efficacy of DIFINISA53™, a safe silibin-based skin cream, on preventing radiation dermatitis (RD) when compared to an over the counter ointment, Aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or mastectomy surgery. Presently there is no known fully effective topical protectant from RD and there is no consensus among radiation oncologists on how best to treat RD. This study seeks to identify a more effective option for patients receiving radiation therapy. Each participant will apply the DIFINISA53™ cream to one area of the treated skin and Aquaphor to another area of treated skin. Skin reactions will be evaluated using medical professional assessment, participant assessment, and photographic assessment by a third party.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Difinsa53, Drug: AquaphorRadiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients 18 years and older
- Pathologic diagnosis of breast cancer requiring radiation therapy to whole breast
- Able to apply lotion to treatment area at least twice daily during radiation course
- All surgical sites healed
- No evidence of infection
Key exclusion criteria (5 listed)
- Prior history of radiation therapy (RT) to that site
- Known dermatologic conditions affecting skin in radiation port
- Concurrent chemotherapy
- Skin infection in radiation port
- History of sensitivity to Aquaphor or Difensa53 component
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 |
|---|---|---|
| Difinsa53Also: DimethiconeDifinsa53 cream is applied to one half of radiation field | Drug | Single Arm |
| AquaphorAlso: petrolatumAquaphor is applied to one half of radiation field | Drug | Single Arm |
Primary outcome
Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria
Time frame: 8 weeks
A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21514477McQuestion M. Evidence-based skin care management in radiation therapy: clinical update. Semin Oncol Nurs. 2011 May;27(2):e1-17. doi: 10.1016/j.soncn.2011.02.009.
- Background: PubMed 21786113Becker-Schiebe M, Mengs U, Schaefer M, Bulitta M, Hoffmann W. Topical use of a silymarin-based preparation to prevent radiodermatitis : results of a prospective study in breast cancer patients. Strahlenther Onkol. 2011 Aug;187(8):485-91. doi: 10.1007/s00066-011-2204-z. Epub 2011 Jul 22.
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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.
Joshua Petit, MD principal investigator
UC Health, Poudre Valley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Difinsa53 and Aquaphor in people with Radiodermatitis, run by ProTechSure Scientific, Inc. 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 6 Oct 2017. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02534129, which also lists 2 linked publications.
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 6 Oct 2017.