radiation dermatitis
Conditions
Interventions
The experimental group:TDX105 granules + basic therapy
The control group:Hirudoid cream + basic therapy
Sponsors
Beijing Hospital of TCM, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Malignant tumor was definitely diagnosed and radiotherapy was given. 2. Acute radiation-induced skin injury was diagnosed according to the diagnostic criteria for radiation-induced skin diseases (GBZ106-2002), and radiodermatitis (Grades I–III) was diagnosed according to RTOG. 3. Age from 18 to 75 years (including boundary value). 4. The ECOG PS score was <= 3 points and the estimated survival time was =3 months. 5. Agree to participate in this study and sign informed consent form.
Exclusion criteria
Exclusion criteria: 1. The observed skin lesions combined with skin damage or lesions caused by other reasons, including: acne, eczema, psoriasis and other primary skin lesions; peripheral neuropathy caused by diabetes; skin fungal infection; skin trauma and inflammation; allergic dermatitis; connective tissue disease. 2. Non-radiation-induced skin toxicity reactions occur in distant parts outside of radiation local skin lesions, such as HFSR caused by chemotherapy or targeted drugs, and skin lesion manifestations of immune-related adverse events (IRAEs), such as Stevens-Johnson syndrome. 3. Pregnant during the pregnancy or lactation period, or if the pregnancy is scheduled to occur within 6 months after the end of the study. 4. Anyone who suffers from infectious diseases or serious basic diseases, including but not limited to the immune system, blood system, circulatory system, digestive system, respiratory system, urinary system, nervous system and mental system, and is not suitable for participation in this study after evaluation by the researcher. 5. Known to be allergic to drugs used in this study. 6. Are participating in clinical trials of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RTOG; | — |
Secondary
| Measure | Time frame |
|---|---|
| The Radiation-Induced Skin Reaction Assessent Scale,RISRAS;Dermatology Life Quality Index,DLQI;Numerical Rating Scale,NRS;Visual Analogue Scale,VAS;Effective/healing time;Time to relapse after effectiveness/recovery;Appearance of lesion; | — |
Countries
China
Contacts
Public ContactGuowang Yang
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Outcome results
None listed