N/A
N=25
KeraStat(R) Cream for Radiation Dermatitis
Radiation Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT03559218 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Radiation Therapy Oncology Group Skin Toxicity Scoring — 0.00; 0.00; 0.09; 0.15 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- KeraStat(R) Cream (Device); Standard of care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- KeraNetics, LLC
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiation Therapy Oncology Group Skin Toxicity Scoring |
0.00; 0.00; 0.09; 0.15; 0.55; 0.62 | — |
| PRIMARY Dermatology Life Quality Index |
2.73; 0.31; 1.64; 0.77; 1.91; 2.23 | — |
| SECONDARY Number of Participants With Adverse Events |
0; 0 | — |
Summary
The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 70
- Female
- Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)
- 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
- Autoimmune disease
- Skin disease in target irradiation area
- Known allergy to the standard of care or ingredients in KeraStat Cream
Data sourced from ClinicalTrials.gov (NCT03559218). 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.