The effect of betamethasone cream in preventing radiation skin reaction in head and neck cancers

Comparison of best supportive care with or without 0.1% Topical Betamethasone valerate as a prophylactic agent for acute Radiation Dermatitis in Head and Neck Malignancies: a randomised controlled study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/04/008298

Enrollment

150

Registered

2017-04-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients getting Radical Radiotherapy in Head and Neck malignancies

Interventions

Intervention1: Topical 0.1% Betamethasone Valerate: Betamethasone cream topical application is the intervention. An even coating of 0.1% Betomethasone will be applied over the entire radiation field w

Eligibility

Inclusion criteria

Inclusion criteria: Patients should be recieving radical RT,With ECOG 1&2

Exclusion criteria

Exclusion criteria: Previously irradiated,connective tissue disorder,allergy to cream

Design outcomes

Secondary

Measure	Time frame
To assess patientsâ?? skin related quality of life using EORTC QLQ-H&N 35 quality of life scores Timepoint: At start of treatment and completion of treatment;To assess toxicities of topical application of 0.1% Betamethasone cream. Timepoint: From start of radiotherapy to 2 weeks following completion;To evaluate 0.1% Topical Betamethasone cream as an interventional agent in Radiation dermatitis based on time to develop grade 2,3,4 dermatitis Timepoint: from start of radiotherapy to 2 weeks following completion	—

Measure

Time frame

To assess patientsâ?? skin related quality of life using EORTC QLQ-H&N 35 quality of life scores Timepoint: At start of treatment and completion of treatment;To assess toxicities of topical application of 0.1% Betamethasone cream. Timepoint: From start of radiotherapy to 2 weeks following completion;To evaluate 0.1% Topical Betamethasone cream as an interventional agent in Radiation dermatitis based on time to develop grade 2,3,4 dermatitis Timepoint: from start of radiotherapy to 2 weeks following completion

—

Primary

Measure	Time frame
efficacy of 0.1% Topical Betamethasone cream in decreasing the proportion of patients with Grade 2,3,4 radiation dermatitis in Head and Neck malignanciesTimepoint: from start of radiotherapy to 2 weeks following completion	—

Countries

India

Contacts

Public ContactDr Abhilash Menon

JIPMER

menonabhilash18@gmail.com9495188300

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 26, 2026