Topical Periplaneta Americana-Derived Meilian Fuxin Liquid for Radiation Dermatitis

NCT07353671 | Recruiting Phase 2

• 1 other identifier: 2025(1723)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Radiation-induced Dermatitis

Keywords

Head & neck cancer; Radiation-induced Dermatitis; Meilian Fuxin Solution

Outcome Measures

Primary Outcomes (1)

• 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.

  The evaluation period is approximately 14 weeks to 14.5 weeks.

Secondary Outcomes (7)

• Incidence of Grade 3 or Grade 4 Radiation Dermatitis

  The evaluation period is approximately 14 weeks and 14.5 weeks.

• Time to Occurrence of Grade 3 or Grade 4 Radiation Dermatitis

  The evaluation period is approximately 14 weeks to 14.5 weeks.

• The duration of any-grade Radiation Dermatitis

  The evaluation period is approximately 14 weeks and 14.5 weeks.

• Change in Radiation Dermatitis Severity Score using the RISRAS Scale

  The evaluation period is approximately 14 weeks and 14.5 weeks.

• Change in Patient Quality of Life using the Skindex-16

  The evaluation period is approximately 14 weeks and 14.5 weeks.

Other Outcomes (3)

• Overall Health Status and Core Dimensions of Quality of Life

  The total evaluation period is approximately 14 to 14.5 weeks.

• Head and Neck Cancer-Specific Symptoms

  The total evaluation period is approximately 14 to 14.5 weeks.

• The number of patients who missed five or more consecutive radiation fractions

  The evaluation period is approximately 6 weeks and 6.5 weeks.

Study Arms (2)

Meilian Fuxin Solution

EXPERIMENTAL

Topical application of Periplaneta americana-derived Meilian Fuxin Solution

Drug: Topical application of Periplaneta americana-derived Meilian Fuxin Solution; Radiation: Radiotherapy

Control group

PLACEBO COMPARATOR

Topical application of placebo

Other: Topical application of placebo; Radiation: Radiotherapy

Interventions

Topical application of Periplaneta americana-derived Meilian Fuxin Solution DRUG

A topical formulation derived from Periplaneta americana (Meilian Fuxin Solution).

Also known as: MLFX, Periplaneta Americana Extract, Meilian Fuxin Ye

Meilian Fuxin Solution

Topical application of placebo OTHER

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.

Control group

Radiotherapy RADIATION

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.

Control group; Meilian Fuxin Solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (2)

Sichuan University West China Hospital, Chengdu, Sichuan

Chengdu, Sichuan, 610041, China

RECRUITING

Sichuan University West China Hospital

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Radiodermatitis; Head and Neck Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xingchen Peng

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng

CONTACT

+86 18980606753; pxx2014@163.com

Ruiwan Yuan

CONTACT

yuanruiwan@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: January 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)