What question did this study set out to answer?

This study aims to assess the efficacy and safety of ALA-PDT for treating Bowen's disease in Chinese patients.

January 20, 2026Open Access

5‐Aminolevulinic Acid–Based Photodynamic Therapy (ALA‐PDT) for Bowen’s Disease in Chinese Patients: A Multicenter Prospective Study

MRMenglong Ran YTYang TangKunming Medical University WWWenyu WuFudan University

Key Points

This study aims to assess the efficacy and safety of ALA-PDT for treating Bowen's disease in Chinese patients.
Conducted as a multicenter, prospective clinical study across seven hospitals in China.
Involved histopathologically confirmed Bowen's disease patients treated with 20% ALA gel or solution.
Lesions were illuminated with 635-nm red LED light after a 3-4 hour incubation.
Patients received 3-6 sessions of ALA-PDT, with follow-ups scheduled every 7-14 days.
Achieved a complete response rate of 97.1% for patients and 97.7% for lesions after treatment.
During the 12-month follow-up, the recurrence rate was 3.0%.
93.1% of physicians rated cosmetic effects as excellent or good, and patient satisfaction was 92.6%.
The primary adverse event was mild to moderate pain, with 100% of lesions showing brick-red fluorescence.

Abstract

Background In China, the common treatment for Bowen’s disease (BD) is surgical excision. Although 5‐aminolevulinic acid–based photodynamic therapy (ALA‐PDT) has proven effective for BD in Caucasian patients, there is limited research on its effectiveness in Asian patients. This trial aimed to investigate the efficacy and safety of ALA‐PDT in treating BD patients in China, providing data to standardize its application in Chinese BD patients. Methods A multicenter, prospective clinical study was conducted in seven tertiary hospitals in China. Histopathologically confirmed BD patients received standard ALA‐PDT. After pretreatment, a 20% ALA gel or solution was applied to the lesions and incubated for 3‐4 h. The lesions were illuminated with 635‐nm red LED light at a dose level of 80–120 J/cm 2 . Additional treatments were scheduled every 7–14 days based on lesion regression. Results The study included 35 BD patients with 44 lesions. All patients received 3–6 sessions of ALA‐PDT. Three months after the last treatment, the complete response rate was 97.1% (34/35) for patients and 97.7% (43/44) for lesions. Subgroup analysis indicated that sex ( p = 0.3518), age ( p = 0.6906), number of lesions ( p = 0.7155), lesion location ( p = 0.2241), and size ( p = 0.2898) did not significantly affect effectiveness. During the 12‐month follow‐up, the recurrence rate was 3.0% (1/33). Physicians rated 93.1% (27/29) of cosmetic effects as excellent or good. Meanwhile, patient satisfaction reached 92.6% (25/27). The primary adverse event observed was mild to moderate pain. Photodynamic fluorescence diagnosis showed that 100% (35/35) of the BD lesions exhibited brick‐red fluorescence. Conclusions A regimen of 3–6 sessions of topical ALA‐PDT using 20% ALA, 3‐4‐h incubation, and a red light source leads to high complete response rates, excellent cosmetic effects, good patient tolerance, and minimal adverse reactions in Chinese BD patients. Importantly, the efficacy of ALA‐PDT is not affected by lesion size, location, or number. Trial Registration: Chinese Registry of Clinical Trials: ChiCTR1800019213

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