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Clinical Efficacy Study of Radiation Dermatitis Traditional Chinese Medicine Syndrome Specification for RenZhong White Oil Ointment

Clinical Efficacy Study of Radiation Dermatitis Traditional Chinese Medicine Syndrome Specification for RenZhong White Oil Ointment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001528
Enrollment
Unknown
Registered
2025-07-30
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumor of breast

Interventions

RenZhong White Oil Ointment group: RenZhong White Oil Ointment
Ailuosong formation:Mometasone Furoate Cream

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Female aged = 18 and = 75 years; 2) Patients who have received standard radical surgery for breast cancer and have been pathologically diagnosed as early breast cancer; 3) Patients who have completed radiotherapy and meet the diagnosis of grade II Rd; 4) Received = 15 fractionated treatments (total = 40gy); 5) The local syndrome differentiation of RD skin lesions is desquamation type; 6) ECoG score 0-2; 7) Those who understand and agree to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Observe the skin lesions or lesions caused by other reasons including: acne eczema psoriasis allergic dermatitis connective tissue disease and other primary skin lesions; 2) Skin toxicity caused by non radiotherapy occurs in radiation local skin lesions such as hfsr caused by chemotherapy or targeted drugs skin damage manifestations of immunotherapy related adverse events such as Stevens Johnson syndrome etc; 3) Peripheral neuropathy caused by diabetes or other basic diseases; Fungal infection of skin; Skin trauma and inflammation; 4) Suffering from serious basic diseases including but not limited to immune system blood system circulatory system digestive system respiratory system urinary system nervous system and mental system and the disease symptoms assessed by the investigator are not suitable for participation in this study; 5) Those who suffer from mental illness language disorder or are unable to cooperate with the data collector for other reasons; 6) Those in pregnancy or lactation (excluded by blood HCG); 7) A history of systemic or local use of antibiotics antifungal drugs and glucocorticoids within 2 weeks; 8)The patient is currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
RTOG recovery rate after 4 weeks of treatment;

Secondary

MeasureTime frame
Changes of skin erythema, edema and epidermal exfoliation (EASI);Changes in RTOG and CTCAE grades;Changes in visual analogue scale (VAS) of skin pain;Bacterial culture of skin swabs;Barrier function and skin pH;Skin itch (NRS) changes;Changes in skindex-16 scores;

Countries

China

Contacts

Public ContactDong Mengting

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine

Nancyd33@163.com13817170419

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026