Radiation DermatitisPhase 1NCT06001463
Clinical Trial of CSMed Wound Dressing for Radiation Dermatitis
A Phase 1 study testing CSMed Dressing in people with Radiation Dermatitis, run by Chung Shan Medical University at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- CSMed Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2020to 31 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Radiation Dermatitis
- Being tested
- CSMed Dressing
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSMed DressingDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CSMed Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jun 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueh-Chun Lee, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001463
- Sponsor's protocol ID
- CS1 20015
- Status last verified
- Aug 2023
- First submitted
- 21 Feb 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSMed Wound Dressing on Radiation Dermatitis Clinical Trial
- ClinicalTrials.gov ID
- NCT06001463
- Acronym / sponsor ID
- CS1 20015
- Conditions
- Radiation Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the effects of CSMed® for preventing and managing radiation dermatitis in patients with Breast cancer and Head-Neck cancer receiving radiotherapy (≥50 Gy).
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| reduce the severity, and enhance healing of radiation dermatitis | Experimental | Drug: CSMed DressingThe patient received part of the breast/neck skin CSMed® dressing or clinical routine skin care. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSMed DressingHalf 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. | Drug | reduce the severity, and enhance healing of radiation dermatitis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Radiation Dermatitis
RecruitingPhase 2
A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
Breast Cancer, Breast Cancer Female
RecruitingObservational study
Collecting Patient-Reported Experiences With Radiation Dermatitis in Breast Cancer Patients Undergoing Radiotherapy
Breast Carcinoma
RecruitingPhase 2
Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer
Radiation-induced Dermatitis
Not yet recruiting
Artificial Intelligence Powered Digital Education Based on the Neuman Systems Model for Breast Cancer Patients Receiving Radiotherap
Breast Cancer, Radiodermatitis
Not yet recruitingObservational study
Determinants of Radiation Dermatitis in Head and Neck Cancer Patients Receiving Preventive Photobiomodulation
Head and Neck Neoplasms, Radiodermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CSMed Dressing in people with Radiation Dermatitis, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of acute radiation dermatitis (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.