Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis

August 23, 2023 updated by: Yueh-Chun Lee, Chung Shan Medical University

CSMed Wound Dressing on Radiation Dermatitis Clinical Trial

Investigate the effects of CSMed® for preventing and managing radiation dermatitis in patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 408025
        • Chung Shan Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: reduce the severity, and enhance healing of radiation dermatitis
The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of acute radiation dermatitis
Time Frame: 4 weeks

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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS1 20015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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