An Early Phase 1 interventional study of Adapalene gel 0.1% and Biafine topical emulsion in Dermatitis, Radiation-Induced and Adapalene, sponsored by Yunnan Cancer Hospital. Recruiting at 1 site in China. Open to female participants. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Yunnan Cancer Hospital · Early Phase 1, Interventional, and Prevention
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.
This study will evaluate the efficacy and safety of topical vitamin A acid/retinoid for acute radiation dermatitis in oncology patients receiving definitive radiotherapy to the chest, head and neck, or abdomen/pelvis. Eligible participants will have developed grade I-III acute radiation-induced skin injury during radiotherapy. After confirmation of skin lesions, standardized topical retinoid treatment will be started. Clinical skin reaction grade within the radiation field, local skin imaging findings, peripheral blood inflammatory markers, symptoms/adverse events, and quality of life will be assessed at 3-5 prespecified time points during radiotherapy and follow-up. The study aims to define the appropriate timing, dosage, safety monitoring, and clinical benefit of topical retinoid in different grades of radiation dermatitis.
139 studies on the registry are indexed under Radiodermatitis; 26 are open to participants now.
This study's planned enrollment of 50 is close to the median of 55 across 114 interventional studies indexed under Radiodermatitis.
Browse Radiodermatitis studies →Yunnan Cancer Hospital is the lead sponsor of 29 studies on the registry; 25 are open to participants now.
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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.
Drug: Adapalene gel 0.1%
Intervention Name: Biafine topical emulsion Intervention Type: Drug Other Name: Biafine (trolamine-based topical emulsion) Description: Biafine topical emulsion is a standard topical agent for the prevention and treatment of radiation-induced skin reactions. In this study, it serves as the active comparator. Participants in the control arm will apply Biafine emulsion topically to the irradiated skin field at a dose of 2 g per application, once daily, starting on the first day of radiotherapy and continuing throughout the entire course of radiotherapy (approximately 25 days, i.e., 25 fractions, or until completion of radiotherapy, whichever comes first). Participants will be instructed to gently apply a thin layer to clean, intact skin within the irradiated field and to avoid washing the treated area for at least 4-6 hours after application.
Drug: Biafine topical emulsion
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.
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.
RTOG/EORTC Acute Radiation Morbidity Score for Skin Reactions in the Irradiated Field (Score Range: 0 to 4; Lower Scores Indicate Better Outcome)
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.
Time frame: From randomization through completion of radiotherapy and follow-up, up to 6 weeks.
Plan to share: No — Protect patient privacy
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Started Mar 2026 (actual). Primary completion is estimated for Nov 2026, 8 months after the start.
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Studies of the drug tested here: Adapalene
Yunnan Cancer Hospital