Clinical trial · Interventional
Topical Use of Difinsa53™ to Prevent Radiation Dermatitis
Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer: A Prospective Study
NCT02534129CI-TRIAL-00029814terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient dermatitis was seen in the controls to allow any determination of protection by Difinsa53
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiodermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aquaphor | Drug | — | UNRESOLVED |
| Difinsa53 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor
- interventionNames
- Drug: Difinsa53
- Drug: Aquaphor
Primary outcomes (1)
- measure
- Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria
- timeFrame
- 8 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (2)
- BACKGROUNDMcQuestion 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. PMID 21514477
- BACKGROUNDBecker-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. PMID 21786113