Adapalene gel vs. Biafine for acute radiation dermatitis in adults receiving radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase, randomized trial compares topical adapalene gel 0.1% to Biafine for treating acute radiation-induced skin injury in adults with breast cancer or head and neck cancer. Participants will apply the assigned treatment daily during radiotherapy and visit the clinic every five days for skin assessments, imaging, labs, and symptom reporting. Outcomes include skin reaction severity, safety signals, inflammatory markers, symptoms, and quality of life at multiple time points during treatment and follow-up. The study aims to establish timing, dose, safety monitoring, and potential clinical benefit of topical retinoids for radiation dermatitis across different injury grades.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yunnan Cancer Hospital
  Kunming, Yunnan, China Recruiting

Study contacts

• Study coordinator: 浩瑜 李, graduate student
• Email: 2489181721@qq.com
• Phone: +86 18987725475

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Amino acid–derived antioxidant lipids to prevent and treat radiation skin damage in head and neck cancer

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• Skin-repair cream to prevent radiation dermatitis after breast cancer surgery

  This phase 3 trial tests whether a natural weak-acid skin repair cream can prevent acute radiation dermatitis in adults who had mastectomy and are receiving adjuvant radiotherapy for breast cancer.

  Recruiting Phase 3 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07066280

• ROS-scavenging nanoenzyme prevention for radiation dermatitis in head and neck cancer

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  Recruiting West China Hospital · Chengdu, Sichuan · NCT07064577

• Comparing Betamethasone and Moisturizer for Skin Care in Breast Cancer Patients

  This study is testing whether a skin cream called betamethasone can help prevent skin problems from radiation therapy in large-breasted breast cancer patients compared to using just a moisturizer.

  Recruiting Phase 3 Sunnybrook Health Sciences Centre · Toronto, Ontario · NCT06915857

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.