Radiation DermatitisNCT06484166
Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
A study testing Fullerene cream and Trolamine (Biafine) in people with Radiation Dermatitis, run by West China Hospital at 1 site in China.
Trial summary
Radiotherapy always results in many complications such as radiation dermatitis, dry mouth, cranial nerve damage, and swallowing function. Among them, radiation dermatitis is confirmed to occur in the majority of tumor patients receiving radiotherapy, which not only affects the appearance but also causes the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- Fullerene cream and Trolamine (Biafine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 1 May 2025
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- Patients considered candidates for high-dose RT either as primary treatment or as postoperative treatment after surgical resection and patients planned to receive concomitant boost fractionation or concurrent systemic chemotherapy.
Who cannot join
- Eastern Cooperative Oncology Group performance status of >2;
- Pre-existing skin rash, ulceration or open wound in the treatment area;
- Known allergy to trolamine or fullerene;
- Inflammatory or connective tissue disorder of the skin;
- History of head and neck radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Radiotherapy always results in many complications such as radiation dermatitis, dry mouth, cranial nerve damage, and swallowing function. Among them, radiation dermatitis is confirmed to occur in the majority of tumor patients receiving radiotherapy, which not only affects the appearance but also causes the interruption of radiotherapy in severe cases.
At present, there is no standard treatment for radiation dermatitis. Trolamine is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. Fullerene cream is able to remove free radicals produced during radiotherapy, which may provide a new way and method for the prevention and treatment of radiation dermatitis. In addition, the product has obtained a safety assessment report from a third-party testing organization, proving that it has fully met the applied human body standards.
This clinical trial studies the effect of Fullerene cream in preventing radiation dermatitis in Head and Neck Cancer, compared with trolamine.
Read the detailed description
Radiotherapy (RT) is an important treatment for head and neck malignant tumors and can be used alone or in combination with chemotherapy as radical or adjuvant therapy. Complications such as radiation dermatitis, dry mouth, cranial nerve damage, and poor swallowing function can occur in patients with head and neck cancer undergoing radiotherapy. Data from previous retrospective studies have shown that up to 90% of patients with head and neck tumors will develop radiation dermatitis after radiotherapy. Radiation dermatitis may cause the radiotherapy interrupted and treatment time prolonged, which will ultimately affect the treatment outcome and overall quality of life.
At present, there is no standard treatment for radiation dermatitis. Trolamine (Biafine; Genmedix Ltd, France) is an oil-in-water emulsion that can enhance skin healing by recruiting macrophages and modifying the concentrations of various immunomodulators. In China, Trolamine is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity.
Fullerene is hollow molecules made entirely of carbon, with the ability to remove free radicals produced during radiotherapy. At the same time, Fullerene cream contains active ingredients such as ecdoine and sodium hyaluronate, which can effectively promote collagen production and speed up the repair of damaged skin. In addition, the product has obtained a safety assessment report from a third-party testing organization, proving that it has fully met the applied human body standards.
This clinical trial studies the effect of Fullerene cream in preventing radiation dermatitis in Head and Neck Cancer, compared with trolamine.
- Conditions
- Radiation Dermatitis
- Being tested
- Fullerene cream, Trolamine (Biafine)
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fullerene creamOther
Patients are instructed to apply a thin layer of the Fullerene cream third a day, starting three days before radiotherapy(RT) and continue until two weeks after treatment. The application should include the whole treatment area. Patients are also advised to not apply the cream within four hours before the RT in order to avoid possible build-up effect. Patients are asked to keep the skin of the radiotherapy area dry and clean and not use other topical agents in the irradiated area.
Trolamine (Biafine)Drug
Patients are instructed to apply a thin layer of the Trolamine (Biafine) third a day, starting three days before radiotherapy(RT) and continue until two weeks after treatment. The application should include the whole treatment area. Patients are also advised to not apply the cream within four hours before the RT in order to avoid possible build-up effect. Patients are asked to keep the skin of the radiotherapy area dry and clean and not use other topical agents in the irradiated area.
| Study group | Role | What they receive |
|---|---|---|
| Trolamine (Biafine) | Active comparator | Trolamine (Biafine; Genmedix Ltd, France) is cream packed in an opaque white bottle of 50g each, which is the same as the experimental group in appearance. Receives: Drug: Trolamine (Biafine) |
| Fullerene cream | Experimental | Fullerene cream is cream packed in an opaque white bottle of 50g each, which is the same as the control group in appearance. Receives: Other: Fullerene cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade 2 or higher radiation dermatitis.
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale. The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis. Grade 0 means no change over baseline. Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating. Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema. Grade 3 means confluent, moist desquamation other than skin folds; pitting edema. Grade 4 means ulceration, hemorrhage, necrosis.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Secondary outcomes (7)
The time to onset of grade 2 or higher radiation dermatitis.
Time from the first day of radiotherapy to the first determination of grade 2 or higher radiation dermatitis.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The duration of grade 2 or higher radiation dermatitis.
The first determination of grade 2 or higher radiation dermatitis to the first instance of grade 1 or 0 radiation dermatitis, without a subsequent instance of grade 2 or higher radiation dermatitis. Patients without observed grade 2 or higher radiation dermatitis were assigned a duration of 0 days.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The maximum skin toxicity.
The maximum grade of RTOG skin toxicity between 0 and 4.
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The Skindex-16 instrument.
The Skindex-16 is a commonly used tool to measure the effect of skin diseases on the QoL of patients. Skindex-16 consists of domain scores that assess how symptoms, emotions, and functioning from the skin issue affect the QOL of patients with acne. The overall score averages the 3 domain scores, all of which are normalized to a 0 to 100 scale, where 0 indicates that their skin condition has no impact on QOL and 100 represents maximal impact on QOL for the worse.
Measured: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
EORTC QLQ-C30.
The EORTC QLQ-C30 consists of five functional scales, nine symptom scales and one global quality of life (QoL) scale, and has been validated in an international setting.The questionnaire uses a four-point Likert scale to indicate the extent of problems experienced, ranging from 'not at all' to 'very much'. The answers for each domain are converted to a score ranging from 0 to 100；or functional scales, high scores represent a high level of QoL，and for symptom scales high scores indicate a poor QoL.
Measured: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
EORTC QLQ-H&N35
The EORTC QLQ-H\&N35 covers issues specific to HNC patients and includes 18 symptom scales; it has been validated in an international setting and is used extensively in HRQoL research. The questionnaire uses a four-point Likert scale to indicate the extent of problems experienced, ranging from 'not at all' to 'very much'. The answers for each domain are converted to a score ranging from 0 to 100；or functional scales, high scores represent a high level of QoL，and for symptom scales high scores indicate a poor QoL.
Measured: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
Adverse events.
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version.
Measured: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Aug 2024
- Primary completion1 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484166
- Sponsor's protocol ID
- HX2024-134
- Status last verified
- May 2025
- First submitted
- 24 Jun 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Z, Liu X, Li Z, Xie J, Gao K, Pei Y, Gu Z, Peng X. Fullerene for Reducing Acute Radiation Dermatitis in Patients Undergoing Radiotherapy for Head and Neck Cancer: A Phase II, Double-Blind, Randomized Controlled Trial. J Clin Oncol. 2026 May;44(13):1206-1215. doi: 10.1200/JCO-25-02264. Epub 2026 Mar 20.
PubMed 41861269
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
- ClinicalTrials.gov ID
- NCT06484166
- Acronym / sponsor ID
- HX2024-134
- Conditions
- Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 3 Jul 2024 (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.
Radiotherapy always results in many complications such as radiation dermatitis, dry mouth, cranial nerve damage, and swallowing function. Among them, radiation dermatitis is confirmed to occur in the majority of tumor patients receiving radiotherapy, which not only affects the appearance but also causes the interruption of radiotherapy in severe cases.
At present, there is no standard treatment for radiation dermatitis. Trolamine is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. Fullerene cream is able to remove free radicals produced during radiotherapy, which may provide a new way and method for the prevention and treatment of radiation dermatitis. In addition, the product has obtained a safety assessment report from a third-party testing organization, proving that it has fully met the applied human body standards.
This clinical trial studies the effect of Fullerene cream in preventing radiation dermatitis in Head and Neck Cancer, compared with trolamine.
Detailed description
Radiotherapy (RT) is an important treatment for head and neck malignant tumors and can be used alone or in combination with chemotherapy as radical or adjuvant therapy. Complications such as radiation dermatitis, dry mouth, cranial nerve damage, and poor swallowing function can occur in patients with head and neck cancer undergoing radiotherapy. Data from previous retrospective studies have shown that up to 90% of patients with head and neck tumors will develop radiation dermatitis after radiotherapy. Radiation dermatitis may cause the radiotherapy interrupted and treatment time prolonged, which will ultimately affect the treatment outcome and overall quality of life.
At present, there is no standard treatment for radiation dermatitis. Trolamine (Biafine; Genmedix Ltd, France) is an oil-in-water emulsion that can enhance skin healing by recruiting macrophages and modifying the concentrations of various immunomodulators. In China, Trolamine is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity.
Fullerene is hollow molecules made entirely of carbon, with the ability to remove free radicals produced during radiotherapy. At the same time, Fullerene cream contains active ingredients such as ecdoine and sodium hyaluronate, which can effectively promote collagen production and speed up the repair of damaged skin. In addition, the product has obtained a safety assessment report from a third-party testing organization, proving that it has fully met the applied human body standards.
This clinical trial studies the effect of Fullerene cream in preventing radiation dermatitis in Head and Neck Cancer, compared with trolamine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trolamine (Biafine) | Active comparator | Drug: Trolamine (Biafine)Trolamine (Biafine; Genmedix Ltd, France) is cream packed in an opaque white bottle of 50g each, which is the same as the experimental group in appearance. |
| Fullerene cream | Experimental | Other: Fullerene creamFullerene cream is cream packed in an opaque white bottle of 50g each, which is the same as the control group in appearance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- Patients considered candidates for high-dose RT either as primary treatment or as postoperative treatment after surgical resection and patients planned to receive concomitant boost fractionation or concurrent systemic chemotherapy.
Key exclusion criteria (5 listed)
- Eastern Cooperative Oncology Group performance status of >2;
- Pre-existing skin rash, ulceration or open wound in the treatment area;
- Known allergy to trolamine or fullerene;
- Inflammatory or connective tissue disorder of the skin;
- History of head and neck radiotherapy.
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 |
|---|---|---|
| Fullerene creamPatients are instructed to apply a thin layer of the Fullerene cream third a day, starting three days before radiotherapy(RT) and continue until two weeks after treatment. The application should include the whole treatment area. Patients are also advised to not apply the cream within four hours before the RT in order to avoid possible build-up effect. Patients are asked to keep the skin of the radiotherapy area dry and clean and not use other topical agents in the irradiated area. | Other | Fullerene cream |
| Trolamine (Biafine)Patients are instructed to apply a thin layer of the Trolamine (Biafine) third a day, starting three days before radiotherapy(RT) and continue until two weeks after treatment. The application should include the whole treatment area. Patients are also advised to not apply the cream within four hours before the RT in order to avoid possible build-up effect. Patients are asked to keep the skin of the radiotherapy area dry and clean and not use other topical agents in the irradiated area. | Drug | Trolamine (Biafine) |
Primary outcome
The incidence of grade 2 or higher radiation dermatitis.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale. The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis. Grade 0 means no change over baseline. Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating. Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema. Grade 3 means confluent, moist desquamation other than skin folds; pitting edema. Grade 4 means ulceration, hemorrhage, necrosis.
7 secondary outcomes
The time to onset of grade 2 or higher radiation dermatitis.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The duration of grade 2 or higher radiation dermatitis.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The maximum skin toxicity.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
The Skindex-16 instrument.
Time frame: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
EORTC QLQ-C30.
Time frame: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
EORTC QLQ-H&N35
Time frame: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
Adverse events.
Time frame: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
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 4 Jun 2025.
- Derived from this study: PubMed 41861269Liu Z, Liu X, Li Z, Xie J, Gao K, Pei Y, Gu Z, Peng X. Fullerene for Reducing Acute Radiation Dermatitis in Patients Undergoing Radiotherapy for Head and Neck Cancer: A Phase II, Double-Blind, Randomized Controlled Trial. J Clin Oncol. 2026 May;44(13):1206-1215. doi: 10.1200/JCO-25-02264. Epub 2026 Mar 20.
- Individual participant dataSharing planned: No
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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.
Xingchen Peng principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fullerene cream and Trolamine (Biafine) in people with Radiation Dermatitis, run by West China Hospital at 1 site in China.
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 5 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 4 Jun 2025. 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 China. 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.
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?
The incidence of grade 2 or higher radiation dermatitis. (time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06484166, which also lists 1 linked publication.
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 4 Jun 2025.