N/A
N=28
Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy
Head and Neck Cancer · Radiation Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT04173247 ↗Enrolled (actual)
28
Serious AEs
12.5%
Results posted
Sep 2023
Primary outcome: Primary: Completion Rate of Use of KeraStat Cream — 10; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- KeraStat Cream (Device); Routine Skin Care - Commercially Available Agents (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion Rate of Use of KeraStat Cream |
10; 7 | — |
| SECONDARY Number of Participants Discontinuing Skin Care Regimen |
0; 0 | — |
| SECONDARY Number of Participants With Grade 2+ Radiation Dermatitis |
9; 7 | — |
| SECONDARY Number of Participants Reporting Radiation Skin Reaction |
8; 10 | — |
| SECONDARY Dermatology Life Quality Index Questionnaire |
1.5; 1.9 | 0.28 |
| SECONDARY Number of Tubes of KeraStat Cream Used to Calculate Skin Coverage |
49 | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04173247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.