Adapalene Gel for Acute Radiation-Induced Skin Injury

NCT07886320 | Recruiting Early Phase 1

• 1 other identifier: KYLX2026-333
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dermatitis, Radiation-Induced; Adapalene

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization through completion of radiotherapy and follow-up, up to 6 weeks.

Study Arms (2)

Adapalene

EXPERIMENTAL

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%

Biafine

ACTIVE COMPARATOR

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

Interventions

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.

Adapalene

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.

Biafine

Eligibility Criteria

• Gender Eligibility Details: Primarily targeting breast cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, 65000, China

RECRUITING

MeSH Terms

Conditions

Radiodermatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Central Study Contacts

浩瑜 李, graduate student

CONTACT

+86 18987725475; 2489181721@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: his is a single-center, investigator-initiated, open-label, randomized controlled trial using a parallel, two-arm intervention model. Eligible adult oncology patients receiving definitive radiotherapy who develop grade I-III acute radiation dermatitis will be randomized \[1:1\] to topical adapalene gel or Biafine/active comparator. Randomization sequence will be generated by \[computer-generated sequence/software\], with allocation concealment maintained by \[central randomization system/sequentially numbered sealed opaque envelopes\]. Because the interventions are administered topically and open-label, participants and treating investigators will not be blinded; where feasible, \[photographic/skin-grade outcome assessors\] will be blinded to group assignment. Study medication will be applied \[once/twice daily\] from confirmation of qualifying skin injury until \[completion of radiotherapy/skin healing, per protocol\]. Rescue medication, permitted/prohibited concomitant skin treatments, dose inte

Study Record Dates

• First Submitted: September 29, 2026
• First Posted: October 21, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)