Radiation-Induced Skin InjuryPhase 1AKK-RISNCT07635277
Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
A Phase 1 study testing AKK Topical Preparation in people with Radiation-Induced Skin Injury, run by West China Hospital at 2 sites in China.
Trial summary
This study is a multicenter, open-label, Phase I single-arm clinical trial evaluating the safety and tolerability of a topical AKK probiotic preparation (Akkermansia muciniphila) for the prevention and treatment of radiation-induced skin injury in patients receiving radiotherapy for breast cancer, head and neck cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiation-Induced Skin Injury
- What is being tested?
- AKK Topical Preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 7 Jun 2026to 31 Dec 2026
- Phase
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of breast cancer, head and neck cancer (including nasopharyngeal carcinoma) receiving radiotherapy
- Age ≥18 years and ≤75 years, any sex
- Signed written informed consent
- Radiation field skin area can be localized and skin inflammation can be assessed
- ECOG performance status 0-1, life expectancy ≥3 months
- Adequate major organ function
- Fertile patients (both sexes) must use effective medical contraception during the study and for 6 months after the last dose
- Willing to comply with follow-up and skin image collection
Who cannot join
- Cognitive impairment preventing understanding of the study
- Use of antibiotics or antifungals within 1 month
- Previous treatment with other bacterial preparations
- Participation in other bacterial therapy trials
- Any abnormality (e.g., scar, tattoo) in the radiation field that would interfere with assessment
- Allergy to probiotics or any component of the study preparation; history of severe allergic reactions (e.g., anaphylaxis, angioedema, respiratory distress, allergic purpura, Arthus reaction)
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- Use of immunosuppressive drugs
- Symptomatic or rapidly progressive central nervous system metastases, extensive lung metastases causing dyspnea, tumor invading major vessels or nerves
- Poorly controlled cardiac disease (NYHA class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring treatment)
- Pregnancy or breastfeeding
- Active tuberculosis, bacterial or fungal infection (grade ≥2 per CTCAE), or HIV infection
- Substance abuse or psychiatric disorder
- Active autoimmune disease or history thereof (exceptions: vitiligo, childhood asthma fully resolved with no intervention in adulthood)
- History of alcohol or drug abuse
- Planned pregnancy from screening until 12 months after last treatment
- Any concomitant condition that, in the investigator's judgment, would compromise patient safety or study completion
- Any other condition deemed unsuitable for enrollment by the investigator
- Inability to provide written informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Xuelei Ma, +8613408410416, drmaxuelei@gmail.com
- Recruiting
Jintang County First People's Hospital
Chengdu, Sichuan, 610400
Lei Zhang, +8618908070191, 314189929@qq.com
About this study
Official title: Clinical Application of AKK Bacterial Preparation for the Treatment of Radiation-Induced Skin Injury
This study is a multicenter, open-label, Phase I single-arm clinical trial evaluating the safety and tolerability of a topical AKK probiotic preparation (Akkermansia muciniphila) for the prevention and treatment of radiation-induced skin injury in patients receiving radiotherapy for breast cancer, head and neck cancer (including nasopharyngeal carcinoma). A total of 40 participants are planned to receive the AKK preparation applied to the radiation field three times daily, starting one day before the first radiotherapy fraction and continuing until 14 days after the last fraction. The primary outcome is the incidence of grade ≥2 acute radiation dermatitis (ARD) assessed by RTOG and CTCAE criteria. Secondary outcomes include changes in skin micro-features under digital dermoscopy, skin microbiota composition, quality of life (Skindex-16), and safety.
Read the detailed description
Background and Rationale Radiation-induced skin injury (RISI) affects approximately 95% of radiotherapy patients in China, with 85% experiencing moderate to severe acute radiation dermatitis (ARD). Current topical treatments have limited efficacy. Akkermansia muciniphila (AKK), a commensal gut bacterium, exhibits anti-inflammatory and barrier-repairing properties via NF-κB, Nrf2, and NLRP3 pathways. This is the first study to apply inactivated AKK topically for RISI.
Detailed Intervention The investigational product is an inactivated whole-cell AKK preparation (provided by State Key Laboratory of Biotherapy, Sichuan University). Participants apply 140 µL per 25 cm² of radiation field (delivering 7 × 10⁷ CFU) three times daily: once 1 hour before each radiotherapy fraction, and twice at other times (e.g., afternoon and bedtime). Treatment begins one day before the first fraction (after baseline skin sampling) and continues until 14 days after the last fraction.
Study Procedures After written informed consent, screening (D-28 to D-1) includes history, physical exam, and ECOG performance status. At baseline (D-1): skin microbiome sampling, digital dermoscopy, RTOG/CTCAE grading, and Skindex-16. During radiotherapy, weekly visits (on the first fraction day of each week, before that fraction) repeat all assessments. Treatment phase duration varies by fraction number (15, 25, 30, or 33 fractions). Follow-up visits occur at days 14 after the last fraction, with the same assessments. Adverse events are monitored throughout and graded by CTCAE v6.0.
Sample Size Justification Assuming historical incidence of grade ≥2 ARD = 50%, expected incidence with AKK = 30% (one-sided α=0.05, power=80%), the required sample size is 37. Accounting for 8% dropout, final N = 40.
Statistical Analysis Primary analysis uses intention-to-treat population. Incidence of grade ≥2 ARD will be compared to historical control using a one-sample proportion test. Secondary endpoints (skin microbiome, dermoscopy features, Skindex-16, adverse events) will be summarized descriptively with 95% confidence intervals. Continuous variables will be compared using paired t-tests or Wilcoxon signed-rank tests as appropriate.
Data Monitoring A Data Safety Monitoring Committee (DSMC) composed of oncologists, pharmacologists, biostatisticians, and GCP experts will review safety and efficacy data every 6 months and may recommend early termination or protocol modification based on predefined stopping rules (e.g., grade 4 AEs in >10% of participants).
Ethical Approval The protocol (version 2.0, 4 February 2026) and informed consent form (version 2.0, 4 February 2026) were approved by the Medical Ethics Committee of West China-Jintang Hospital, Sichuan University (approval No. 20260302002, dated 2 March 2026). Any amendments will be submitted for ethical review before implementation.
- Conditions
- Radiation-Induced Skin Injury
- Being tested
- AKK Topical Preparation
- Keywords
- Acute Radiation Dermatitis, Radiation-Induced Skin Injury, Akkermansia muciniphila, AKK, Topical Probiotic, Breast Cancer, Head and Neck Cancer
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKK Topical PreparationBiological
Inactivated whole-cell Akkermansia muciniphila topical preparation. Dose: 140 µL per 25 cm² of radiation field (7 × 10⁷ CFU). Applied three times daily: once 1 hour before each radiotherapy fraction, and twice at other times (e.g., afternoon and bedtime). Treatment begins one day before the first radiotherapy fraction (after baseline skin sampling) and continues until 14 days after the last radiotherapy fraction.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: AKK Topical Preparation | Experimental | Not described Receives: Biological: AKK Topical Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade ≥2 Acute Radiation Dermatitis
Proportion of participants developing grade 2 or higher acute radiation dermatitis (ARD) as assessed by RTOG and CTCAE v6.0 criteria during radiotherapy and follow-up.
Measured: From first radiotherapy fraction up to 90 days after the last fraction
Secondary outcomes (7)
Changes in Skin Micro-Features on Digital Dermoscopy
Evolution of skin micro-features (e.g., erythema, scaling, vascular changes) observed by digital dermoscopy during treatment and follow-up.
Measured: Baseline, weekly during radiotherapy, and at days 14, 30, 60, 90 after last radiotherapy fraction.
Skin Microbiota Composition
Changes in the relative abundance of skin bacterial species measured from desquamated scale samples.
Measured: Same as above.
Frequency of Grade ≥3 Acute Radiation Dermatitis
Proportion of participants developing grade 3 or higher ARD assessed by RTOG/CTCAE v6.0.
Measured: From first radiotherapy fraction to 90 days after last fraction.
Duration of Grade 2/3/4 Acute Radiation Dermatitis
Number of days from first onset to resolution of grade 2, 3, or 4 ARD.
Measured: During radiotherapy and up to 90 days after last fraction.
Incidence of Grade 2 ARD at 2 Weeks Post-Radiotherapy
Proportion of participants with grade 2 ARD at 14 days after the last radiotherapy fraction.
Measured: Day 14 after last radiotherapy fraction.
Frequency of Local Infection
Occurrence of clinically diagnosed infection within the irradiated skin area.
Measured: From first radiotherapy fraction to 90 days after last fraction.
Other Adverse Events
Type, frequency, severity, and relationship to study treatment of adverse events graded by CTCAE v6.0.
Measured: From informed consent to 90 days after last radiotherapy fraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start7 Jun 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-Induced Skin InjuryStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China-Jintang Hospital, Sichuan University
- Responsible party
- Principal investigator, Xuelei Ma MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635277
- Sponsor's protocol ID
- 20260302002
- Other IDs
- AKK-RIS-2026-V2.0
- Acronym
- AKK-RIS
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of AKK Bacterial Preparation for the Treatment of Radiation-Induced Skin Injury
- ClinicalTrials.gov ID
- NCT07635277
- Acronym / sponsor ID
- AKK-RIS / 20260302002
- Conditions
- Radiation-Induced Skin Injury
- Keywords
- Acute Radiation Dermatitis, Radiation-Induced Skin Injury, Akkermansia muciniphila, AKK, Topical Probiotic, Breast Cancer, Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- West China-Jintang Hospital, Sichuan University
- Study start
- 7 Jun 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jun 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.
This study is a multicenter, open-label, Phase I single-arm clinical trial evaluating the safety and tolerability of a topical AKK probiotic preparation (Akkermansia muciniphila) for the prevention and treatment of radiation-induced skin injury in patients receiving radiotherapy for breast cancer, head and neck cancer (including nasopharyngeal carcinoma). A total of 40 participants are planned to receive the AKK preparation applied to the radiation field three times daily, starting one day before the first radiotherapy fraction and continuing until 14 days after the last fraction. The primary outcome is the incidence of grade ≥2 acute radiation dermatitis (ARD) assessed by RTOG and CTCAE criteria. Secondary outcomes include changes in skin micro-features under digital dermoscopy, skin microbiota composition, quality of life (Skindex-16), and safety.
Detailed description
Background and Rationale Radiation-induced skin injury (RISI) affects approximately 95% of radiotherapy patients in China, with 85% experiencing moderate to severe acute radiation dermatitis (ARD). Current topical treatments have limited efficacy. Akkermansia muciniphila (AKK), a commensal gut bacterium, exhibits anti-inflammatory and barrier-repairing properties via NF-κB, Nrf2, and NLRP3 pathways. This is the first study to apply inactivated AKK topically for RISI.
Detailed Intervention The investigational product is an inactivated whole-cell AKK preparation (provided by State Key Laboratory of Biotherapy, Sichuan University). Participants apply 140 µL per 25 cm² of radiation field (delivering 7 × 10⁷ CFU) three times daily: once 1 hour before each radiotherapy fraction, and twice at other times (e.g., afternoon and bedtime). Treatment begins one day before the first fraction (after baseline skin sampling) and continues until 14 days after the last fraction.
Study Procedures After written informed consent, screening (D-28 to D-1) includes history, physical exam, and ECOG performance status. At baseline (D-1): skin microbiome sampling, digital dermoscopy, RTOG/CTCAE grading, and Skindex-16. During radiotherapy, weekly visits (on the first fraction day of each week, before that fraction) repeat all assessments. Treatment phase duration varies by fraction number (15, 25, 30, or 33 fractions). Follow-up visits occur at days 14 after the last fraction, with the same assessments. Adverse events are monitored throughout and graded by CTCAE v6.0.
Sample Size Justification Assuming historical incidence of grade ≥2 ARD = 50%, expected incidence with AKK = 30% (one-sided α=0.05, power=80%), the required sample size is 37. Accounting for 8% dropout, final N = 40.
Statistical Analysis Primary analysis uses intention-to-treat population. Incidence of grade ≥2 ARD will be compared to historical control using a one-sample proportion test. Secondary endpoints (skin microbiome, dermoscopy features, Skindex-16, adverse events) will be summarized descriptively with 95% confidence intervals. Continuous variables will be compared using paired t-tests or Wilcoxon signed-rank tests as appropriate.
Data Monitoring A Data Safety Monitoring Committee (DSMC) composed of oncologists, pharmacologists, biostatisticians, and GCP experts will review safety and efficacy data every 6 months and may recommend early termination or protocol modification based on predefined stopping rules (e.g., grade 4 AEs in >10% of participants).
Ethical Approval The protocol (version 2.0, 4 February 2026) and informed consent form (version 2.0, 4 February 2026) were approved by the Medical Ethics Committee of West China-Jintang Hospital, Sichuan University (approval No. 20260302002, dated 2 March 2026). Any amendments will be submitted for ethical review before implementation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: AKK Topical Preparation | Experimental | Biological: AKK Topical Preparation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of breast cancer, head and neck cancer (including nasopharyngeal carcinoma) receiving radiotherapy
- Age ≥18 years and ≤75 years, any sex
- Signed written informed consent
- Radiation field skin area can be localized and skin inflammation can be assessed
- ECOG performance status 0-1, life expectancy ≥3 months
Key exclusion criteria (18 listed)
- Cognitive impairment preventing understanding of the study
- Use of antibiotics or antifungals within 1 month
- Previous treatment with other bacterial preparations
- Participation in other bacterial therapy trials
- Any abnormality (e.g., scar, tattoo) in the radiation field that would interfere with assessment
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 |
|---|---|---|
| AKK Topical PreparationInactivated whole-cell Akkermansia muciniphila topical preparation. Dose: 140 µL per 25 cm² of radiation field (7 × 10⁷ CFU). Applied three times daily: once 1 hour before each radiotherapy fraction, and twice at other times (e.g., afternoon and bedtime). Treatment begins one day before the first radiotherapy fraction (after baseline skin sampling) and continues until 14 days after the last radiotherapy fraction. | Biological | Experimental: AKK Topical Preparation |
Primary outcome
Incidence of Grade ≥2 Acute Radiation Dermatitis
Time frame: From first radiotherapy fraction up to 90 days after the last fraction
Proportion of participants developing grade 2 or higher acute radiation dermatitis (ARD) as assessed by RTOG and CTCAE v6.0 criteria during radiotherapy and follow-up.
7 secondary outcomes
Changes in Skin Micro-Features on Digital Dermoscopy
Time frame: Baseline, weekly during radiotherapy, and at days 14, 30, 60, 90 after last radiotherapy fraction.
Skin Microbiota Composition
Time frame: Same as above.
Frequency of Grade ≥3 Acute Radiation Dermatitis
Time frame: From first radiotherapy fraction to 90 days after last fraction.
Duration of Grade 2/3/4 Acute Radiation Dermatitis
Time frame: During radiotherapy and up to 90 days after last fraction.
Incidence of Grade 2 ARD at 2 Weeks Post-Radiotherapy
Time frame: Day 14 after last radiotherapy fraction.
Frequency of Local Infection
Time frame: From first radiotherapy fraction to 90 days after last fraction.
Other Adverse Events
Time frame: From informed consent to 90 days after last radiotherapy fraction.
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 9 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AKK Topical Preparation in people with Radiation-Induced Skin Injury, run by West China Hospital at 2 sites 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 8 inclusion and 18 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade ≥2 Acute Radiation Dermatitis (time frame: From first radiotherapy fraction up to 90 days after the last fraction). 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 9 Sep 2026.