Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-10 @ 5:42 AM
Study NCT ID:
NCT06484166
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2024-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
Sponsor:
West China Hospital
Organization:
Study Overview
Official Title:
Efficacy of Fullerene in Preventing Radiation Dermatitis in Patients With Head and Neck Cancer .
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Radiotherapy always results in many complications such as radiation dermatitis, dry mouth, cranial nerve damage, and swallowing function. Among them, radiation dermatitis is confirmed to occur in the majority of tumor patients receiving radiotherapy, which not only affects the appearance but also causes the interruption of radiotherapy in severe cases.
At present, there is no standard treatment for radiation dermatitis. Trolamine is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. Fullerene cream is able to remove free radicals produced during radiotherapy, which may provide a new way and method for the prevention and treatment of radiation dermatitis. In addition, the product has obtained a safety assessment report from a third-party testing organization, proving that it has fully met the applied human body standards.
This clinical trial studies the effect of Fullerene cream in preventing radiation dermatitis in Head and Neck Cancer, compared with trolamine.
At present, there is no standard treatment for radiation dermatitis. Trolamine is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. Fullerene cream is able to remove free radicals produced during radiotherapy, which may provide a new way and method for the prevention and treatment of radiation dermatitis. In addition, the product has obtained a safety assessment report from a third-party testing organization, proving that it has fully met the applied human body standards.
This clinical trial studies the effect of Fullerene cream in preventing radiation dermatitis in Head and Neck Cancer, compared with trolamine.
Detailed Description:
Radiotherapy (RT) is an important treatment for head and neck malignant tumors and can be used alone or in combination with chemotherapy as radical or adjuvant therapy. Complications such as radiation dermatitis, dry mouth, cranial nerve damage, and poor swallowing function can occur in patients with head and neck cancer undergoing radiotherapy. Data from previous retrospective studies have shown that up to 90% of patients with head and neck tumors will develop radiation dermatitis after radiotherapy. Radiation dermatitis may cause the radiotherapy interrupted and treatment time prolonged, which will ultimately affect the treatment outcome and overall quality of life.
At present, there is no standard treatment for radiation dermatitis. Trolamine (Biafine; Genmedix Ltd, France) is an oil-in-water emulsion that can enhance skin healing by recruiting macrophages and modifying the concentrations of various immunomodulators. In China, Trolamine is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity.
Fullerene is hollow molecules made entirely of carbon, with the ability to remove free radicals produced during radiotherapy. At the same time, Fullerene cream contains active ingredients such as ecdoine and sodium hyaluronate, which can effectively promote collagen production and speed up the repair of damaged skin. In addition, the product has obtained a safety assessment report from a third-party testing organization, proving that it has fully met the applied human body standards.
This clinical trial studies the effect of Fullerene cream in preventing radiation dermatitis in Head and Neck Cancer, compared with trolamine.
At present, there is no standard treatment for radiation dermatitis. Trolamine (Biafine; Genmedix Ltd, France) is an oil-in-water emulsion that can enhance skin healing by recruiting macrophages and modifying the concentrations of various immunomodulators. In China, Trolamine is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity.
Fullerene is hollow molecules made entirely of carbon, with the ability to remove free radicals produced during radiotherapy. At the same time, Fullerene cream contains active ingredients such as ecdoine and sodium hyaluronate, which can effectively promote collagen production and speed up the repair of damaged skin. In addition, the product has obtained a safety assessment report from a third-party testing organization, proving that it has fully met the applied human body standards.
This clinical trial studies the effect of Fullerene cream in preventing radiation dermatitis in Head and Neck Cancer, compared with trolamine.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: