Adapalene Gel for Acute Radiation-Induced Skin Injury

Condition(s) studied

Investigational drug(s) / intervention(s)

Adapalene gel 0.1%: Intervention Name: Adapalene gel 0.1% Intervention Type: Drug Other Name: Topical retinoid; \[brand name if applicable\] Description: Adapalene gel 0.1% is applied topically to the affected irradiated skin at a dose of 2 g per application, once daily, for 25 days.

Biafine topical emulsion: Intervention Name: Biafine topical emulsion Intervention Type: Drug Other Name: Biafine; \[active ingredient/generic name if applicable, e.g., trolamine-based topical emulsion\] Description: Biafine topical emulsion is applied topically to the affected irradiated skin at a dose of 2 g per application, once daily, for 25 days.

Study summary

his study aims to evaluate whether adapalene gel is effective and safe for treating acute radiation-induced skin injury in adults receiving radiotherapy. Researchers will compare adapalene gel with Biafine to determine whether adapalene gel reduces radiation-induced skin injury and improves symptoms. The main questions are: Does adapalene gel reduce the severity of acute radiation-induced skin injury compared with Biafine, and what medical problems or adverse events occur in participants using adapalene gel? Participants will apply adapalene gel or Biafine topically every day throughout the course of radiotherapy, visit the clinic every 5 days for examinations and tests, and record their symptoms and any adverse reactions during use.

Eligibility

Primary outcome measure(s)

• RTOG/EORTC Acute Radiation Morbidity Score for Skin Reactions in the Irradiated Field (Score Range: 0 to 4; Lower Scores Indicate Better Outcome) — From randomization through completion of radiotherapy and follow-up, up to 6 weeks.
  Skin reaction within the radiation field will be assessed using the unabbreviated Radiation Therapy Oncology Group / European Organisation for Research and Treatment of Cancer (RTOG/EORTC) acute radiation morbidity scoring criteria for skin. The score ranges from a minimum of 0 to a maximum of 4. Lower scores indicate less severe radiation-induced skin injury and a better outcome; higher scores indicate more severe radiation dermatitis and a worse outcome.

Trial sites (1)

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