Clinical trial · Interventional
Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer
Pilot Study: KeraStat Cream for Radiation Dermatitis
NCT03374995CI-TRIAL-00077863completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized pilot clinical trial studies how well topical keratin works in treating radiation dermatitis in patients with breast cancer. Radiation dermatitis is a skin condition that is a common side effect of radiation therapy. The affected skin becomes painful, red, itchy, and blistered. Topical keratin may help to improve skin appearance and hydration in patients with breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Radiation-Induced Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Topical Keratin | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (topical keratin)
- description
- Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).
- interventionNames
- Other: Quality-of-Life Assessment
- Device: Topical Keratin
- type
- ACTIVE_COMPARATOR
- label
- Group II (standard of care)
- description
- Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).
- interventionNames
- Other: Best Practice
- Other: Quality-of-Life Assessment
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of breast cancer, received chemotherapy, and scheduled to receive 4 to 6 weeks of radiation therapy (radiation protocol of 42 Gy+) * Area to be irradiated representing 1-10% of total body surface area (TBSA) * Able and willing to sign protocol consent form * Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes * Able and willing to have photographs of the affected area taken regularly Exclusion Criteria: * Women who are pregnant, lactating/nursing or plan to become pregnant * Previous radiation therapy to the area to be treated with radiation therapy * Receiving palliative radiation therapy * Unhealed or infected surgical sites in the irradiation area * Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed) * Use of oral corticosteroids or topical corticosteroids in the irradiation area * Use of Erbitux * Autoimmune disease * Skin disease in target irradiation area * Smoker * Known allergy to the standard of care or ingredients in KeraStat Cream
References
Publications (0)
Data not yet available
No reference posted for this study.