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Efficacy and safety of photodynamic therapy in the treatment of oral leukoplakia: a randomized parallel controlled clinical trial.

Efficacy and safety of photodynamic therapy in the treatment of oral leukoplakia: a randomized parallel controlled clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077347
Enrollment
Unknown
Registered
2023-11-06
Start date
2023-11-08
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

oral leukoplakia

Interventions

Group A:orally take retinoid acid, 0.4-0.6mg/Kg/day, for 3 months
Group B:Topically applling ALA-Photodynamic Therapy
Group C:Topical laser pretreatment of hyperkeratotic lesions combined with ALA photodynamic therapy

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years; 2. Clinically or pathologically diagnosed as oral leukoplakia(with or without epithelium dysplasia); 3. The results of basic physical examination are normal; 4. Those who participate in the study independently and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.Allergy to light or porphyrins; 2.Histopathologic diagnosis of invasive carcinoma; 3.Those at high risk for local anesthesia; 4.Pregnant or lactating women; 5.Those with other severe mucous diseases; 6.Those with other severe systemic diseases that are not controlled by medication; 7.Those with history of psychiatric disorders, poor general conditions or cognitive impairment who can not to cooperate.

Design outcomes

Primary

MeasureTime frame
lesion size;White spot elimination rate;

Secondary

MeasureTime frame
Elimination time ;degree of roughness;recurrence rate;

Countries

China

Contacts

Public ContactHongmei Zhou

West China College of Stomatology, Sichuan University

acomnet@126.com+86 28 8550 3480

Outcome results

None listed

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