A Multicenter, Randomized Controlled Study of TDX105 Granules in the Treatment of Radiation Dermatitis

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: The experimental group:TDX105 granules + basic therapy;The control group:Hirudoid cream + basic therapy; CONDITION: radiation dermatitis PRIMARY OUTCOME: RTOG; SECONDARY OUTCOME: 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; 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.
Epistemonikos ID: 9752eeec3fc18366e34b7c51e09808ccd3b06637
First added on: Feb 20, 2024