Topical Periplaneta Americana-Derived Meilian Fuxin Liquid for Radiation Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical application of Periplaneta americana-derived Meilian Fuxin Solution, Topical application of placebo, Radiotherapy.
- Who it may be relevant to
- Registry conditions: Radiation-induced Dermatitis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Topical application of Periplaneta americana-derived Meilian Fuxin Solution
A topical formulation derived from Periplaneta americana (Meilian Fuxin Solution). - 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. - 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.
Primary outcome measures
- Incidence of Grade 2 or Higher Acute Radiation Dermatitis (RTOG Criteria) [Time frame: The evaluation period is approximately 14 weeks to 14.5 weeks.]
Secondary outcome measures (7)
- 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 2 centers
- Sichuan University West China Hospital, Chengdu, Sichuan — Chengdu
- Sichuan University West China Hospital — Chengdu
Identifiers
NCT: NCT07353671 · 2025(1723)