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出境医 / 临床实验 / KeraStat(R) Cream for Radiation Dermatitis

KeraStat(R) Cream for Radiation Dermatitis

Study Description
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.


Condition or disease Intervention/treatment Phase
Radiation Dermatitis Device: KeraStat(R) Cream Other: Standard of care Not Applicable

Study Design
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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
Arms and Interventions
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.

Outcome Measures
Primary Outcome Measures :
  1. Patient Recruitment Rate [ Time Frame: 6 months ]
    Number of patients approached for inclusion will be compared to number who enrolled

  2. Estimated device use using total body surface area compared to actual device use measured by patient report [ Time Frame: 6 months ]
    Compliance of use/feasibility will be assessed by measuring estimated patient device use and comparing it to actual use as measured by returned tubes and notes on daily diary.

  3. Compliance with protocol [ Time Frame: 6 months ]
    Amount of cream estimated will be compared to patients' actual use as measured by number of tubes provided versus number of tubes used weekly

  4. Dermatology Life Quality Index [ Time Frame: 6 months ]
    The DLQI measures the impact of dermatological conditions on a patient's quality of life. The DLQI is scored by summing the score of each question (answered from not at all, 0, to very much, 3). The maximum is 30 and the minimum is 0. The higher the score, the greater the impairment of quality of life. Data will be aggregated across treatment groups.

  5. Radiation Therapy Oncology Group Skin Toxicity Scoring [ Time Frame: 6 months ]
    The RTOG will be used to track skin reactions to radiation therapy. No toxicity is considered a 0, while massive toxicity is considered a 4. Data will be aggregated across groups at each time point.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 to 70
  2. Female
  3. Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)
  4. Able and willing to sign protocol consent form
  5. Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
  6. Able and willing to have photographs of the affected area taken regularly

Exclusion Criteria:

  1. Women who are pregnant, lactating/nursing or plan to become pregnant
  2. Previous radiation therapy to the area to be treated with radiation therapy
  3. Receiving palliative radiation therapy
  4. Unhealed or infected surgical sites in the irradiation area
  5. Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
  6. Use of oral corticosteroids or topical corticosteroids in the irradiation area
  7. Autoimmune disease
  8. Skin disease in target irradiation area
  9. Known allergy to the standard of care or ingredients in KeraStat Cream
Contacts and Locations

Locations
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United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
KeraNetics, LLC
Investigators
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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
 (submitted: June 5, 2018)
  • Patient Recruitment Rate [ Time Frame: 6 months ]
    Number of patients approached for inclusion will be compared to number who enrolled
  • Estimated device use using total body surface area compared to actual device use measured by patient report [ Time Frame: 6 months ]
    Compliance of use/feasibility will be assessed by measuring estimated patient device use and comparing it to actual use as measured by returned tubes and notes on daily diary.
  • Compliance with protocol [ Time Frame: 6 months ]
    Amount of cream estimated will be compared to patients' actual use as measured by number of tubes provided versus number of tubes used weekly
  • Dermatology Life Quality Index [ Time Frame: 6 months ]
    The DLQI measures the impact of dermatological conditions on a patient's quality of life. The DLQI is scored by summing the score of each question (answered from not at all, 0, to very much, 3). The maximum is 30 and the minimum is 0. The higher the score, the greater the impairment of quality of life. Data will be aggregated across treatment groups.
  • Radiation Therapy Oncology Group Skin Toxicity Scoring [ Time Frame: 6 months ]
    The RTOG will be used to track skin reactions to radiation therapy. No toxicity is considered a 0, while massive toxicity is considered a 4. Data will be aggregated across groups at each time point.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
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
  • Device: KeraStat(R) Cream
    KeraStat Cream is a cream wound dressing that contains 5% keratin.
  • Other: Standard of care
    Patients will be instructed to follow institutional standard of care for radiation dermatitis
Study Arms  ICMJE
  • Standard of care
    Patients undergoing radiation therapy for breast cancer will be provided instructions for radiation dermatitis per institutional standard of care
    Intervention: Other: Standard of care
  • Experimental: KeraStat Cream
    Patients undergoing radiation therapy for breast cancer will be provided KeraStat Cream for twice daily application.
    Intervention: Device: KeraStat(R) Cream
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
 (submitted: August 12, 2019)
25
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2018)
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:

  1. Age 18 to 70
  2. Female
  3. Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)
  4. Able and willing to sign protocol consent form
  5. Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
  6. Able and willing to have photographs of the affected area taken regularly

Exclusion Criteria:

  1. Women who are pregnant, lactating/nursing or plan to become pregnant
  2. Previous radiation therapy to the area to be treated with radiation therapy
  3. Receiving palliative radiation therapy
  4. Unhealed or infected surgical sites in the irradiation area
  5. Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
  6. Use of oral corticosteroids or topical corticosteroids in the irradiation area
  7. Autoimmune disease
  8. Skin disease in target irradiation area
  9. Known allergy to the standard of care or ingredients in KeraStat Cream
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party KeraNetics, LLC
Study Sponsor  ICMJE KeraNetics, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karen Winfield, MD PhD Wake Forest University Health Sciences
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

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