Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

CSMed Wound Dressing on Radiation Dermatitis Clinical Trial

ID
Name
CS1 20015
Description
Investigate the effects of CSMed® for preventing and managing radiation dermatitis in patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).
Trial arms
Trial start
2020-06-01
Estimated PCD
2021-05-31
Trial end
2021-05-31
Status
Completed
Phase
Early phase I
Treatment
CSMed Dressing
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.
Arms:
reduce the severity, and enhance healing of radiation dermatitis
Size
30
Primary endpoint
Severity of acute radiation dermatitis
4 weeks
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2023-08-25

1 organization

1 product

1 indication

Organization
Chung Shan Medical University
Product
CSMed
Indication
Radiation Dermatitis