Topical Periplaneta Americana-Derived Meilian Fuxin Liquid for Radiation Dermatitis

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWest China Hospital

About this trial

To evaluate the efficacy and safety of topical Periplaneta americana-derived Meilian Fuxin Solution for the prevention of radiation dermatitis in patients undergoing radiotherapy.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Topical application of Periplaneta americana-derived Meilian Fuxin Solution
  • Topical application of placebo
  • Radiotherapy

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators