Topical Periplaneta Americana-Derived Meilian Fuxin Liquid for Radiation Dermatitis

March 24, 2026 updated by: Xingchen Peng, West China Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan University West China Hospital
        • Contact:
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Sichuan University West China Hospital, Chengdu, Sichuan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age and Gender: Patients aged 18 to 80 years (inclusive of boundary values), regardless of gender.
  2. 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.
  3. Performance Status: Patients with an ECOG Performance Status score of 0 to 2.
  4. Consent: Patients who voluntarily agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

  1. Prior Radiotherapy: Patients with a history of prior radiotherapy to the target area.
  2. 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.).
  3. Systemic Diseases: Presence of connective tissue diseases or other systemic dermatoses.
  4. Known Allergies: Known allergy to any component of the investigational product (Meilian Fuxin Solution).
  5. Prior Clinical Research: Participation in other interventional clinical studies within the past 3 months and use of any investigational drugs or devices.
  6. Investigator Discretion: Subjects judged by the investigator to be unsuitable for participation in this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Meilian Fuxin Solution
Topical application of Periplaneta americana-derived Meilian Fuxin Solution
Radiation: Radiotherapy
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.
Drug: Topical application of Periplaneta americana-derived Meilian Fuxin Solution
A topical formulation derived from Periplaneta americana (Meilian Fuxin Solution).
Other Names:
  • MLFX
  • Periplaneta Americana Extract
  • Meilian Fuxin Ye
Placebo Comparator: Control group
Topical application of placebo
Radiation: Radiotherapy
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.
Other: Topical application of placebo
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The evaluation period is approximately 14 weeks to 14.5 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Grade 3 or Grade 4 Radiation Dermatitis
Time Frame: The evaluation period is approximately 14 weeks and 14.5 weeks.
Radiation dermatitis is assessed by trained physicians according to the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria.
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 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.
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.
The first determination of radiation dermatitis to the first instance of non-radiation dermatitis, without a subsequent instance of radiation dermatitis.
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.
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.
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.
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.
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.
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.
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.
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version
The evaluation period is approximately 14 weeks and 14.5 weeks.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Health Status and Core Dimensions of Quality of Life
Time Frame: The total evaluation period is approximately 14 to 14.5 weeks.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) This instrument is a 30-item patient-reported outcome (PRO) measure designed to evaluate core aspects of health-related quality of life in cancer patients, including 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, pain, nausea and vomiting), one global health status/quality of life scale, and 6 single-item symptom measures. Scores are linearly transformed to a range of 0-100. For the functional scales and the global health status scale, higher scores indicate better functional levels or quality of life; for the symptom scales/items, higher scores indicate greater symptom burden.
The total evaluation period is approximately 14 to 14.5 weeks.
Head and Neck Cancer-Specific Symptoms
Time Frame: The total evaluation period is approximately 14 to 14.5 weeks.
The EORTC QLQ-H&N35 is a patient-reported outcome (PRO) instrument specifically designed to assess disease-related symptoms and treatment-related side effects in patients with head and neck cancer. It comprises 35 items, organized into seven multi-item subscales (pain, swallowing, senses, speech, social eating, social contact, and sexuality) and eleven single-item measures (such as dental problems, problems opening mouth, sticky saliva, coughing, etc.). All subscale and single-item scores are linearly transformed to a 0-100 scale using a standardized scoring algorithm. Interpretation of Scores: For all subscales and single items, higher scores represent more severe symptoms or greater symptom burden.
The total evaluation period is approximately 14 to 14.5 weeks.
The number of patients who missed five or more consecutive radiation fractions
Time Frame: The evaluation period is approximately 6 weeks and 6.5 weeks.
The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.
The evaluation period is approximately 6 weeks and 6.5 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West China Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xingchen Peng, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025(1723)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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