Radiation-induced DermatitisPhase 2/3NCT07353671
Topical Periplaneta Americana-Derived Meilian Fuxin Liquid for Radiation Dermatitis
A Phase 2/3 study testing Topical application of Periplaneta americana-derived Meilian Fuxin Solution and Radiotherapy in people with Radiation-induced Dermatitis, run by West China Hospital at 2 sites in China.
Trial summary
To evaluate the efficacy and safety of topical Periplaneta americana-derived Meilian Fuxin Solution for the prevention of radiation dermatitis in patients undergoing radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation-induced Dermatitis
- What is being tested?
- Topical application of Periplaneta americana-derived Meilian Fuxin Solution and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2026to 30 Jun 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age and Gender: Patients aged 18 to 80 years (inclusive of boundary values), regardless of gender.
- Diagnosis and Treatment: Patients with head and neck cancer (including nasopharyngeal carcinoma) who have been confirmed by histopathology and require radical radiotherapy or postoperative adjuvant radiotherapy.
- Performance Status: Patients with an ECOG Performance Status score of 0 to 2.
- Consent: Patients who voluntarily agree to participate in this study and sign the informed consent form.
Who cannot join
- Prior Radiotherapy: Patients with a history of prior radiotherapy to the target area.
- Baseline Skin Condition: Baseline skin condition in the treatment area that may interfere with efficacy assessment (e.g., presence of open wounds, infection, rash, psoriasis, etc.).
- Systemic Diseases: Presence of connective tissue diseases or other systemic dermatoses.
- Known Allergies: Known allergy to any component of the investigational product (Meilian Fuxin Solution).
- Prior Clinical Research: Participation in other interventional clinical studies within the past 3 months and use of any investigational drugs or devices.
- Investigator Discretion: Subjects judged by the investigator to be unsuitable for participation in this clinical study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ruiwan Yuan contact
China2 sites, 2 recruiting
- Recruiting
Sichuan University West China Hospital, Chengdu, Sichuan
Chengdu, Sichuan, 610041
Xingchen Peng, +86 18980606753, pxx2014@163.com
- Recruiting
Sichuan University West China Hospital
Chengdu, Sichuan
Xingchen Peng, +86 18980606753, pxx2014@163.com
About this study
Official title: A Single-Center, Two-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of a Topical Periplaneta Americana-Derived Regenerative Solution (Meilian Fuxin Liquid) for the Treatment of Radiation Dermatitis
To evaluate the efficacy and safety of topical Periplaneta americana-derived Meilian Fuxin Solution for the prevention of radiation dermatitis in patients undergoing radiotherapy.
Read the detailed description
The clinical trial aims to evaluate the efficacy and safety of topical Periplaneta americana-derived Meilian Fuxin Solution in preventing and reducing radiation dermatitis in patients undergoing radiotherapy. Participants will be assigned to receive either topical Meilian Fuxin Solution or a placebo formulation, applied twice daily to the irradiated skin area from the start of radiotherapy through completion of treatment. The placebo will be administered using an identical application regimen. Radiation dermatitis will be assessed at baseline and at regular intervals during and after radiotherapy using the Radiation Therapy Oncology Group (RTOG) criteria, and safety will be evaluated by monitoring local and systemic adverse events throughout the study period.
- Conditions
- Radiation-induced Dermatitis
- Being tested
- Topical application of Periplaneta americana-derived Meilian Fuxin Solution, Topical application of placebo, Radiotherapy
- Keywords
- Head & neck cancer, Radiation-induced Dermatitis, Meilian Fuxin Solution
- Medical subject headings
- Radiodermatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical application of Periplaneta americana-derived Meilian Fuxin SolutionDrug
Also called MLFX, Periplaneta Americana Extract, Meilian Fuxin Ye
A topical formulation derived from Periplaneta americana (Meilian Fuxin Solution).
Topical application of placeboOther
The placebo topical formulation will be composed of inactive ingredients and will be matched in appearance, texture, and administration regimen to the active Periplaneta americana-derived Meilian Fuxin Solution, and participants will also receive standard skin care for radiation dermatitis according to institutional clinical practice guidelines.
RadiotherapyRadiation
One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Meilian Fuxin Solution | Experimental | Topical application of Periplaneta americana-derived Meilian Fuxin Solution Receives: Drug: Topical application of Periplaneta americana-derived Meilian Fuxin Solution; Radiation: Radiotherapy |
| Control group | Placebo comparator | Topical application of placebo Receives: Other: Topical application of placebo; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 2 or Higher Acute Radiation Dermatitis (RTOG Criteria)
Acute radiation dermatitis is assessed by trained radiation oncologists according to the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria. The RTOG grading system categorizes acute radiation dermatitis into grades 0 to 4, with higher grades indicating more severe skin reactions. Grade 0 indicates no visible skin changes; Grade 1 indicates faint erythema or dry desquamation; Grade 2 indicates moderate to brisk erythema or patchy moist desquamation, mainly confined to skin folds; Grade 3 indicates confluent moist desquamation outside of skin folds or bleeding induced by minor trauma; and Grade 4 indicates skin necrosis or ulceration of full-thickness dermis, or spontaneous bleeding. The incidence of Grade 2 or higher acute radiation dermatitis is defined as the proportion of participants who develop Grade 2, Grade 3, or Grade 4 dermatitis at any time during radiotherapy or within the post-radiotherapy follow-up period.
Measured: The evaluation period is approximately 14 weeks to 14.5 weeks.
Secondary outcomes (7)
Incidence of Grade 3 or Grade 4 Radiation Dermatitis
Radiation dermatitis is assessed by trained physicians according to the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria.
Measured: The evaluation period is approximately 14 weeks and 14.5 weeks.
Time to Occurrence of Grade 3 or Grade 4 Radiation Dermatitis
The time from the start of radiotherapy to the first documented occurrence of Grade 3 or Grade 4 radiation dermatitis, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria.
Measured: The evaluation period is approximately 14 weeks to 14.5 weeks.
The duration of any-grade Radiation Dermatitis
The first determination of radiation dermatitis to the first instance of non-radiation dermatitis, without a subsequent instance of radiation dermatitis.
Measured: The evaluation period is approximately 14 weeks and 14.5 weeks.
Change in Radiation Dermatitis Severity Score using the RISRAS Scale
The change in radiation dermatitis severity, as measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS), which ranges from 0 to 24, with higher scores indicating more severe skin reactions. Scores will be assessed at baseline (before the first day of radiotherapy), weekly during radiotherapy, and at follow-up visits up to 8 weeks after completion of radiotherapy.
Measured: The evaluation period is approximately 14 weeks and 14.5 weeks.
Change in Patient Quality of Life using the Skindex-16
The change in patient-reported quality of life related to skin symptoms, as measured by the Skindex-16 Dermatology Life Quality Instrument, which ranges from 0 to 100, with higher scores indicating worse quality of life. Scores will be assessed at baseline (before the first day of radiotherapy), weekly during radiotherapy, and at follow-up visits up to 8 weeks after completion of radiotherapy.
Measured: The evaluation period is approximately 14 weeks and 14.5 weeks.
Radiotherapy Interruption due to Radiation Dermatitis
The occurrence of any temporary interruption, delay, or discontinuation of radiotherapy attributable to radiation dermatitis, as documented in the medical record. The reason for interruption will be confirmed by the treating radiation oncologist.
Measured: The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks.
Adverse events
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version
Measured: The evaluation period is approximately 14 weeks and 14.5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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
- NCT07353671
- Sponsor's protocol ID
- 2025(1723)
- Status last verified
- Mar 2026
- First submitted
- 14 Dec 2025
- Last updated
- 25 Mar 2026
- 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 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Two-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of a Topical Periplaneta Americana-Derived Regenerative Solution (Meilian Fuxin Liquid) for the Treatment of Radiation Dermatitis
- ClinicalTrials.gov ID
- NCT07353671
- Acronym / sponsor ID
- 2025(1723)
- Conditions
- Radiation-induced Dermatitis
- Keywords
- Head & neck cancer, Radiation-induced Dermatitis, Meilian Fuxin Solution
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Jan 2026 (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.
To evaluate the efficacy and safety of topical Periplaneta americana-derived Meilian Fuxin Solution for the prevention of radiation dermatitis in patients undergoing radiotherapy.
Detailed description
The clinical trial aims to evaluate the efficacy and safety of topical Periplaneta americana-derived Meilian Fuxin Solution in preventing and reducing radiation dermatitis in patients undergoing radiotherapy. Participants will be assigned to receive either topical Meilian Fuxin Solution or a placebo formulation, applied twice daily to the irradiated skin area from the start of radiotherapy through completion of treatment. The placebo will be administered using an identical application regimen. Radiation dermatitis will be assessed at baseline and at regular intervals during and after radiotherapy using the Radiation Therapy Oncology Group (RTOG) criteria, and safety will be evaluated by monitoring local and systemic adverse events throughout the study period.
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 |
|---|---|---|
| Meilian Fuxin Solution | Experimental | Drug: Topical application of Periplaneta americana-derived Meilian Fuxin Solution, Radiation: RadiotherapyTopical application of Periplaneta americana-derived Meilian Fuxin Solution |
| Control group | Placebo comparator | Other: Topical application of placebo, Radiation: RadiotherapyTopical application of placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age and Gender: Patients aged 18 to 80 years (inclusive of boundary values), regardless of gender.
- Diagnosis and Treatment: Patients with head and neck cancer (including nasopharyngeal carcinoma) who have been confirmed by histopathology and require radical radiotherapy or postoperative adjuvant radiotherapy.
- Performance Status: Patients with an ECOG Performance Status score of 0 to 2.
- Consent: Patients who voluntarily agree to participate in this study and sign the informed consent form.
Key exclusion criteria (6 listed)
- Prior Radiotherapy: Patients with a history of prior radiotherapy to the target area.
- Baseline Skin Condition: Baseline skin condition in the treatment area that may interfere with efficacy assessment (e.g., presence of open wounds, infection, rash, psoriasis, etc.).
- Systemic Diseases: Presence of connective tissue diseases or other systemic dermatoses.
- Known Allergies: Known allergy to any component of the investigational product (Meilian Fuxin Solution).
- Prior Clinical Research: Participation in other interventional clinical studies within the past 3 months and use of any investigational drugs or devices.
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 |
|---|---|---|
| Topical application of Periplaneta americana-derived Meilian Fuxin SolutionAlso: MLFX, Periplaneta Americana Extract, Meilian Fuxin YeA topical formulation derived from Periplaneta americana (Meilian Fuxin Solution). | Drug | Meilian Fuxin Solution |
| Topical application of placeboThe placebo topical formulation will be composed of inactive ingredients and will be matched in appearance, texture, and administration regimen to the active Periplaneta americana-derived Meilian Fuxin Solution, and participants will also receive standard skin care for radiation dermatitis according to institutional clinical practice guidelines. | Other | Control group |
| RadiotherapyOne of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy. | Radiation | Control group, Meilian Fuxin Solution |
Primary outcome
Incidence of Grade 2 or Higher Acute Radiation Dermatitis (RTOG Criteria)
Time frame: The evaluation period is approximately 14 weeks to 14.5 weeks.
Acute radiation dermatitis is assessed by trained radiation oncologists according to the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria. The RTOG grading system categorizes acute radiation dermatitis into grades 0 to 4, with higher grades indicating more severe skin reactions. Grade 0 indicates no visible skin changes; Grade 1 indicates faint erythema or dry desquamation; Grade 2 indicates moderate to brisk erythema or patchy moist desquamation, mainly confined to skin folds; Grade 3 indicates confluent moist desquamation outside of skin folds or bleeding induced by minor trauma; and Grade 4 indicates skin necrosis or ulceration of full-thickness dermis, or spontaneous bleeding. The incidence of Grade 2 or higher acute radiation dermatitis is defined as the proportion of participants who develop Grade 2, Grade 3, or Grade 4 dermatitis at any time during radiotherapy or within the post-radiotherapy follow-up period.
7 secondary outcomes
Incidence of Grade 3 or Grade 4 Radiation Dermatitis
Time frame: The evaluation period is approximately 14 weeks and 14.5 weeks.
Time to Occurrence of Grade 3 or Grade 4 Radiation Dermatitis
Time frame: The evaluation period is approximately 14 weeks to 14.5 weeks.
The duration of any-grade Radiation Dermatitis
Time frame: The evaluation period is approximately 14 weeks and 14.5 weeks.
Change in Radiation Dermatitis Severity Score using the RISRAS Scale
Time frame: The evaluation period is approximately 14 weeks and 14.5 weeks.
Change in Patient Quality of Life using the Skindex-16
Time frame: The evaluation period is approximately 14 weeks and 14.5 weeks.
Radiotherapy Interruption due to Radiation Dermatitis
Time frame: The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks.
Adverse events
Time frame: The evaluation period is approximately 14 weeks and 14.5 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- 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.
Ruiwan Yuan contact
Xingchen Peng principal investigator
West China Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Topical application of Periplaneta americana-derived Meilian Fuxin Solution and Radiotherapy in people with Radiation-induced Dermatitis, run by West China Hospital at 2 sites 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng (+86 18980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 2 or Higher Acute Radiation Dermatitis (RTOG Criteria) (time frame: The evaluation period is approximately 14 weeks to 14.5 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 Mar 2026.