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Topical Diclofenac for Prevention of Radiation-induced Dermatitis

NCT06905561 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-04-03

No results posted yet for this 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.

Conditions

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.

Sponsors & Collaborators

  • The Second Affiliated Hospital of Hainan Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-13
Primary Completion
2026-06-30
Completion
2026-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06905561 on ClinicalTrials.gov