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A Exploratory Study on the Effect of Laser Pretreatment Combined with Local Bleomycin Therapy in the Treatment of Oral Leukoplakia

A Exploratory Study on the Effect of Laser Pretreatment Combined with Local Bleomycin Therapy in the Treatment of Oral Leukoplakia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118938
Enrollment
Unknown
Registered
2026-02-12
Start date
2026-02-12
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral leukoplakia

Interventions

Bleomycin Treatment Group:Lesions were preconditioned when necessary, followed by topical application of bleomycin (BLM) via wet dressing.

Sponsors

Peking University School and Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with clinically and histopathologically confirmed oral leukoplakia (OLK); 2. Aged >= 18 years, with no restriction on sex; 3. Patients with lesions larger than 1 cm in maximum diameter who are not suitable candidates for local excisional treatment; 4. Able and willing to provide written informed consent to participate in the clinical trial.

Exclusion criteria

Exclusion criteria: 1. Patients with malignant transformation of oral leukoplakia (OLK); 2. Patients who have undergone clinical examination only without histopathological confirmation; 3. History of radiotherapy to the head and neck region; 4. Presence of other malignancies outside the oral cavity; 5. Pregnant or breastfeeding individuals, and minors; 6. Patients with rapidly progressive systemic diseases; 7. History of HIV infection or active hepatitis B or hepatitis C; 8. Patients unable to comply with the study protocol for any reason; 9. History of betel quid chewing.

Design outcomes

Primary

MeasureTime frame
Rate of change in lesion area;

Secondary

MeasureTime frame
Improvement in clinical symptoms;Pathological and molecular changes;Cytological changes;Safety outcomes;

Countries

China

Contacts

Public ContactPeiru Zhou

Peking University School of Stomatology

zhoupeiru1989@163.com+86 10 8219 5349

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026