Topical Diclofenac for Prevention of Radiation-induced Dermatitis
Condition(s) studied
Investigational drug(s) / intervention(s)
Diclofenac Sodium Gel: Diclofenac Sodium Gel were applied to the skin of the irradiated site triple a day a day from the date of first radiotherapy until end of radiotherapy or until the test side skin developed ≥grade 3 RID.
Placebo gel: The placebo does not contain the active ingredients of Jalosome, only the co-formulants.
Study summary
Radiation induced dermatitis (RID) is one of the leading adverse events of radiation therapy, and if occurred could alter the course of therapy. The main pathways of RID is inflammation and oxidative stress on local and systemic bases. The Diclofenac is a COX-2 inhibitor and Nonsteroidal anti-inflammatory drugs whose anti-inflammatory and antioxidant activities have been proven in several clinical trials. Thus, the aim of the present study is to evaluate the efficacy of Diclofenac sodium gel as a prophylactic method against the development of RID.
Eligibility
Primary outcome measure(s)
- Incidence of development of grade ≥ 2 RID — From the first day of radiotherapy until 2 weeks after the end of radiotherapy
If the patient developed grade ≥ 2 RID or not, RTOG standards were used for evaluation
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Second Affiliated Hospital of Hainan Medical University | Haikou | Hainan | Recruiting |
More The Second Affiliated Hospital of Hainan Medical University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06905561 on ClinicalTrials.gov ↗ ← All trials in China