A Phase 1 interventional study of AKK Topical Preparation in Radiation-Induced Skin Injury, sponsored by West China Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by West China Hospital · Phase 1, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
Biological: AKK Topical Preparation
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.
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.
Time frame: From first radiotherapy fraction up to 90 days after the last fraction
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 14 after last radiotherapy fraction.
Frequency of Local Infection
Occurrence of clinically diagnosed infection within the irradiated skin area.
Time frame: 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.
Time frame: From informed consent to 90 days after last radiotherapy fraction.
Plan to share: Yes
Supporting information: Study protocol
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West China Hospital