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RECRUITING
NCT06905561
NA

Topical Diclofenac for Prevention of Radiation-induced Dermatitis

Sponsor: The Second Affiliated Hospital of Hainan Medical University

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

OTHER

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