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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06001463
Other study ID # CS1 20015
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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