Adapalene Gel for Acute Radiation-Induced Skin Injury

NCT07886320 — Early Phase 1, Recruiting, 50 participants, Yunnan Cancer Hospital

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A Single-Center, Open-Label, Randomized Controlled Trial Evaluating the Efficacy and Safety of Adapalene Gel in Patients Receiving Radiotherapy Who Develop Acute Radiation Dermatitis

Registry	NCT07886320, acronym YNSZLYY-RADGEL
Status	Recruiting
Phase	Early Phase 1
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	50 (Estimated)
Sponsor	Yunnan Cancer Hospital (Other)
Conditions	Dermatitis, Radiation-Induced, Adapalene
Interventions	Adapalene gel 0.1%, Biafine topical emulsion (Drug)
Dates	start 2026-03-01, primary completion 2026-11-30 (estimated), completion 2026-11-30 (estimated), first posted 2026-10-21, last updated 2026-10-21
Locations	1 site in China

-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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Adapalene	Experimental	Drug: 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	Active comparator	Drug: Biafine topical emulsion	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.

Adapalene gel 0.1% (Drug): 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 (Drug): 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.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: Female

Inclusion Criteria:

* Informed consent: All subjects must voluntarily participate in the study and sign a written informed consent form that meets the requirements of the ethics committee.
* Male or female, aged between 18 and 75 years.
* Histologically or cytologically confirmed breast cancer or squamous cell carcinoma of the head and neck.
* Planned to receive involved-field radiotherapy (post-breast cancer surgery whole breast/chest wall ± regional lymph node irradiation).

Exclusion Criteria:

* Patients unable to cooperate with the study: cognitive impairment, severe mental illness, communication disorders, or other reasons (such as extreme anxiety, uncontrollable pain) that prevent understanding and active cooperation with the research process and postoperative care.
* Any previous or current illnesses, treatments, or laboratory abnormalities that may confound the study results, affect the subjects' full participation in the study, or involve participation that may not be in the subjects' best interests.

+Locations (1)

Facility	City	Country	Status
Yunnan Cancer Hospital	Kunming, Yunnan	China	Recruiting