The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.
The secondary objectives are to assess the safety and tolerability of KeraStat Cream in subjects at risk of radiation dermatitis, to assess the effectiveness of KeraStat Cream and how that compares to the current standard of care, and to estimate the amount of KeraStat Cream used per patient and coverage on skin.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Radiation Dermatitis | Device: KeraStat(R) Cream Other: Standard of care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Study: KeraStat(R) Cream for Radiation Dermatitis |
Actual Study Start Date : | April 11, 2018 |
Actual Primary Completion Date : | November 6, 2018 |
Actual Study Completion Date : | November 6, 2018 |
Arm | Intervention/treatment |
---|---|
Standard of care
Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care
|
Other: Standard of care
Patients will be instructed to follow institutional standard of care for radiation dermatitis
|
Experimental: KeraStat Cream
Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.
|
Device: KeraStat(R) Cream
KeraStat Cream is a cream wound dressing that contains 5% keratin.
|
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Wake Forest School of Medicine | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Karen Winfield, MD PhD | Wake Forest University Health Sciences |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | March 19, 2018 | ||||||||
First Posted Date ICMJE | June 18, 2018 | ||||||||
Last Update Posted Date | August 14, 2019 | ||||||||
Actual Study Start Date ICMJE | April 11, 2018 | ||||||||
Actual Primary Completion Date | November 6, 2018 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
Incidence of Adverse Events [ Time Frame: 6 months ] Evaluate safety and tolerability of application of KeraStat Cream through comparison of adverse events reported in KeraStat Cream group versus standard of care.
|
||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | KeraStat(R) Cream for Radiation Dermatitis | ||||||||
Official Title ICMJE | Pilot Study: KeraStat(R) Cream for Radiation Dermatitis | ||||||||
Brief 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. The secondary objectives are to assess the safety and tolerability of KeraStat Cream in subjects at risk of radiation dermatitis, to assess the effectiveness of KeraStat Cream and how that compares to the current standard of care, and to estimate the amount of KeraStat Cream used per patient and coverage on skin. |
||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
Condition ICMJE | Radiation Dermatitis | ||||||||
Intervention ICMJE |
|
||||||||
Study Arms ICMJE |
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Actual Enrollment ICMJE |
25 | ||||||||
Original Estimated Enrollment ICMJE |
24 | ||||||||
Actual Study Completion Date ICMJE | November 6, 2018 | ||||||||
Actual Primary Completion Date | November 6, 2018 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03559218 | ||||||||
Other Study ID Numbers ICMJE | KSCM-CRD-001 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE |
|
||||||||
Responsible Party | KeraNetics, LLC | ||||||||
Study Sponsor ICMJE | KeraNetics, LLC | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | KeraNetics, LLC | ||||||||
Verification Date | June 2018 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |