Radiation DermatitisEarly Phase 1YNSZLYY-RADGELNCT07886320
Adapalene Gel for Acute Radiation-Induced Skin Injury
A Early Phase 1 study testing Adapalene gel 0.1% and Biafine topical emulsion in people with Radiation Dermatitis, run by Yunnan Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- Adapalene gel 0.1% and Biafine topical emulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 65000
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Radiation Dermatitis
- Being tested
- Adapalene gel 0.1%, Biafine topical emulsion
- Keywords
- Adapalene, Radiation Dermatitis, Randomized Controlled Trial
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 emulsionDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Biafine topical emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization through completion of radiotherapy and follow-up, up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Mar 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886320
- Sponsor's protocol ID
- KYLX2026-333
- Other IDs
- KYLX2026-333
- Acronym
- YNSZLYY-RADGEL
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protect patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07886320
- Acronym / sponsor ID
- YNSZLYY-RADGEL / KYLX2026-333
- Conditions
- Radiation Dermatitis
- Keywords
- Adapalene, Radiation Dermatitis, Randomized Controlled Trial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 emulsionIntervention 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Adapalene |
| Biafine topical emulsionIntervention 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. | Drug | Biafine |
Primary outcome
RTOG/EORTC Acute Radiation Morbidity Score for Skin Reactions in the Irradiated Field (Score Range: 0 to 4; Lower Scores Indicate Better Outcome)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. Protect patient privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Adapalene gel 0.1% and Biafine topical emulsion in people with Radiation Dermatitis, run by Yunnan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact 浩瑜 李, graduate student (+86 18987725475, 2489181721@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RTOG/EORTC Acute Radiation Morbidity Score for Skin Reactions in the Irradiated Field (Score Range: 0 to 4; Lower Scores Indicate Better Outcome) (time frame: From randomization through completion of radiotherapy and follow-up, up to 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.