Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis

Sponsor

Chung Shan Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT06001463

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Radiation Dermatitis	Drug: CSMed Dressing	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

CSMed Wound Dressing on Radiation Dermatitis Clinical Trial

Actual Study Start Date :

Jun 1, 2020

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

May 31, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Severity of acute radiation dermatitis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chung Shan Medical University	Taichung		Taiwan	408025

Sponsors and Collaborators

Chung Shan Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yueh-Chun Lee, Radiation Oncology Attending Physician, Chung Shan Medical University

ClinicalTrials.gov Identifier:

NCT06001463

Other Study ID Numbers:

CS1 20015

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 25, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dermatitis

Radiodermatitis

Study Results

No Results Posted as of Aug 25, 2023