Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis

Radiation Dermatitis Clinical Trial

Official title:

CSMed Wound Dressing on Radiation Dermatitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06001463
• Other study ID #: CS1 20015
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2023
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks