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Topical Diclofenac for Prevention of Radiation-induced Dermatitis
Sponsor: The Second Affiliated Hospital of Hainan Medical University
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.
Official title: Topical Diclofenac for Prevention of Radiation-induced Dermatitis: A Single-center, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2025-02-13
Completion Date
2026-08-31
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China