Back to resultsClinical Trial of CSMed Wound Dressing for Radiation Dermatitis
Primary Purpose
Radiation Dermatitis
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
CSMed Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Dermatitis
Eligibility Criteria
Inclusion Criteria: Patients receiving radiation therapy (including undamaged skin and RTOG grade 1 dermatitis). Patients who voluntarily agree to participate in the trial and sign the subject's consent form. Exclusion Criteria: Patients with dermatitis and burns not caused by radiation therapy. Involuntary patients without signed consent. Those who are allergic to the ingredients in this product.
Sites / Locations
- Chung Shan Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
reduce the severity, and enhance healing of radiation dermatitis
Arm Description
The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care.
Outcomes
Primary Outcome Measures
Severity of acute radiation dermatitis
The severity of radiation dermatitis can be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1 to 5.
NCI CTCAE grade 1 - Faint erythema with dry desquamation. NCI CTCAE grade 2 - Moderate dermatitis is characterized by moderate to brisk erythema and patchy, moist desquamation mostly confined to skin folds and creases.
NCI CTCAE grade 3 - There is confluent, moist desquamation in locations other than skin folds.
NCI CTCAE grade 4 - This is characterized by skin necrosis or ulceration of full-thickness dermis.
NCI CTCAE grade 5 - Death due to dermatitis alone is a very rare event.
Radiologists performed radiation therapy according to the needs of clinical diseases. Evaluate and record the case after radiotherapy at 4 weeks, and end the research record.
Secondary Outcome Measures
Full Information
NCT ID
NCT06001463
First Posted
February 21, 2023
Last Updated
August 23, 2023
Sponsor
Chung Shan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT06001463
Brief Title
Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis
Official Title
CSMed Wound Dressing on Radiation Dermatitis Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigate the effects of CSMed® for preventing and managing radiation dermatitis in patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).
Detailed Description
A prospective study was conducted at the University Hospital Medical Center. The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care. Record the difference between the part of the skin with dressing and undressed skin for each patient. The severity of acute radiation dermatitis was graded using the RTOG clinical scoring standard. From the beginning of the treatment to 4 weeks after the end of the treatment, skin pain, itching, local fever and tightness, as well as skin healing time were collected every week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
reduce the severity, and enhance healing of radiation dermatitis
Arm Type
Experimental
Arm Description
The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care.
Intervention Type
Drug
Intervention Name(s)
CSMed Dressing
Intervention Description
Half of the irradiated area was covered with CSMed® and the other half was under routine treatment. An irradiated area of 11cm*14cm with best fit or easy accessibility was chosen for CSMed® dressing application. The area without dressing was treated with routine skin care in each patient.
Primary Outcome Measure Information:
Title
Severity of acute radiation dermatitis
Description
The severity of radiation dermatitis can be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1 to 5.
NCI CTCAE grade 1 - Faint erythema with dry desquamation. NCI CTCAE grade 2 - Moderate dermatitis is characterized by moderate to brisk erythema and patchy, moist desquamation mostly confined to skin folds and creases.
NCI CTCAE grade 3 - There is confluent, moist desquamation in locations other than skin folds.
NCI CTCAE grade 4 - This is characterized by skin necrosis or ulceration of full-thickness dermis.
NCI CTCAE grade 5 - Death due to dermatitis alone is a very rare event.
Radiologists performed radiation therapy according to the needs of clinical diseases. Evaluate and record the case after radiotherapy at 4 weeks, and end the research record.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients receiving radiation therapy (including undamaged skin and RTOG grade 1 dermatitis).
Patients who voluntarily agree to participate in the trial and sign the subject's consent form.
Exclusion Criteria:
Patients with dermatitis and burns not caused by radiation therapy.
Involuntary patients without signed consent.
Those who are allergic to the ingredients in this product.
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
ZIP/Postal Code
408025
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis
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