Loading
AKK Topical Preparation / Radiation Induced Skin Injury · Phase 1 Trial
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 1 clinical trial registration evaluating safety and tolerability of topical Akkermansia muciniphila (AKK) for radiation-induced skin injury in cancer patients. No results are reported in this registry record; the trial is currently recruiting. The single-arm, open-label design is appropriate for early safety assessment but provides limited evidence regarding efficacy or comparative benefit.
Phase 1, Interventional, Single Group, Open label, Prevention purpose. Radiation-Induced Skin Injury; age from 18 Years; to 75 Years. Intervention: Experimental: AKK Topical Preparation. n = 40. 2 sites: China.
This is a planned Phase 1 clinical trial registration evaluating safety and tolerability of topical Akkermansia muciniphila (AKK) for radiation-induced skin injury in cancer patients. No results are reported in this registry record; the trial is currently recruiting. The single-arm, open-label design is appropriate for early safety assessment but provides limited evidence regarding efficacy or comparative benefit.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Clinicians should recognize this as an early-stage safety and tolerability study with no reported outcomes. Results, when available, will inform whether further development of topical AKK for radiation dermatitis is warranted; this trial cannot yet establish efficacy or clinical benefit.
Phase 1 single-arm open-label trial with no comparator, designed to assess safety and tolerability of a novel topical probiotic intervention; results are not yet reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should recognize this as an early-stage safety and tolerability study with no reported outcomes. Results, when available, will inform whether further development of topical AKK for radiation dermatitis is warranted; this trial cannot yet establish efficacy or clinical benefit.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07635277). This is a study registration, not published results. Lead sponsor: West China Hospital. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Radiation-Induced Skin Injury. Interventions: BIOLOGICAL: AKK Topical Preparation. Primary outcome measures: Incidence of Grade ≥2 Acute Radiation Dermatitis , From first radiotherapy fraction up to 90 days after the last fraction. Brief 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 (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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.