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An evaluator-blinded randomized controlled trial on the efficiency and safety of photo-dynamic therapy in treating oral leukoplakia, guided with accurate positioning techniques.

An evaluator-blinded randomized controlled trial on the efficiency and safety of photo-dynamic therapy in treating oral leukoplakia, guided with accurate positioning techniques.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16009514
Enrollment
Unknown
Registered
2016-10-20
Start date
2017-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

oral leukoplakia

Interventions

control:orally take retinoid acid, 1-2mg/Kg/day, for 3 months
experiment:topically using 20% ALA gel, after 2 hours, the lesion would be irradiated with laser of 630nm, 100Mw/cm2 or 100J/cm2

Sponsors

Ninth People's Hospital, School of Medicine Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 75 years old; 2. Those who are on first clinical visit, with the clinical and pathological diagnosis of oral leukoplakia; 3. Those who have not received any laser therapy, cryotherapy, radiotherapy or chemotherapy; 4. Those who can tolerate the designed therapy; 5. Those who can read and understand the informed consent form and be willing to attending the trial; 6. Those who are diagnosed as stage III or stage IV in oral leukoplakia, with auto-fluorescence test, DNA image cytometry and pathology.

Exclusion criteria

Exclusion criteria: 1. Those who are pregnant or nursing; 2. Those who are diagnosed as other oral mucosal diseases, tumor or psychopath; 3. Those who have received laser therapy, cryotherapy, radiotherapy or chemotherapy; 4. Those who can not tolerate the designed treatmen.

Design outcomes

Primary

MeasureTime frame
efficiency;

Countries

China

Contacts

Public ContactTang Guoyao

Ninth People's Hospital, School of Medicine Shanghai Jiao Tong University

tanggy@shsmu.edu.cn+86 18221066618

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026