Clinical trial · Interventional
Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy
Pilot Study of KeraStat® Cream for Radiation Dermatitis During Head and Neck Radiotherapy
- 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 is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction (EASR) in patients undergoing radiotherapy to the head and/or neck. Hypothesis: The use of KeraStat Cream in patients receiving radiotherapy for head and neck is feasible, tolerable, and reduces the severity of early adverse skin reaction in the treated region of interest.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KeraStat Cream | Device | — | UNRESOLVED |
| Routine Skin Care - Commercially Available Agents | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KeraStat Skin Cream Arm
- description
- Patients randomized to the KeraStat arm will be provided with KeraStat Skin Cream for application as often as needed but at least twice daily, morning and evening using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
- interventionNames
- Device: KeraStat Cream
- type
- ACTIVE_COMPARATOR
- label
- Routine Skin Care Arm (RSC Arm)
- description
- Patients randomized to this arm will apply commercially available products from a list provided at least twice daily using the product on the start date of radiation and continue until returning for follow up approximately one month after last radiation treatment.
- interventionNames
- Other: Routine Skin Care - Commercially Available Agents
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of head and neck cancer planned to receive conventionally-fractionated definitive radiotherapy to the head and neck to a total prescribed dose of at least 60 Gy * Able and willing to sign protocol consent form * Able and willing to complete tolerability and quality of life assessments * 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 * Active, medically necessary use of topical corticosteroids in the irradiation area * Active scleroderma or lupus requiring systemic medication * Treatment with anti-EGFR antibodies for head and neck cancer (previously or planned)
References
Publications (0)
Data not yet available