Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis

NCT06001463 | Completed Phase 1

• 1 other identifier: CS1 20015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

reduce the severity, and enhance healing of radiation dermatitis

EXPERIMENTAL

The patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care.

Drug: CSMed Dressing

Interventions

CSMed Dressing DRUG

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.

reduce the severity, and enhance healing of radiation dermatitis

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, 408025, Taiwan

Location

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncology Attending Physician

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: August 21, 2023
• Study Start: June 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)