BACKGROUND: Generalised recalcitrant facial verruca plana responds poorly to current therapeutic options, including cryotherapy, topical drugs and carbon dioxide (CO2 ) laser. Case reports and uncontrolled studies suggested that topical photodynamic therapy (PDT) is effective choice of treatment free from potential complications associated with invasive therapies. AIMS: To investigate the efficacy and safety of PDT with different concentrations of photosensitiser in the treatment of verruca plana. MATERIALS & METHODS: The two sides of a subject's face were separately randomized to receive aminolevulinic acid (ALA) of 5%, 10% or 20% concentration. All patients were irradiated with 633-nm red light for 339 J/cm(2) total dose. Complete response (CR) rate was assessed on Week 4, 8, and 16 respectively. RESULTS: The mean overall clearance rate was 74.1%, 68.8%, and 64.6% on Week 4, 8, and 12, respectively, in the 110 treated sides. The CR rate was lower in the 5%-ALA group than in the 10%-ALA group (14.3% vs. 33.3%, p < 0.05) and 20%-ALA group (14.3% vs. 26.3%, p < 0.05) after 12 weeks. The mean severity of pain measured by visual analogue scale (VAS) scoring was 3.8 (range: 2 to 10, depending on the lesion location). The overall recurrence rate was 16.7% (4/24) on Week 12. Hyperpigmentation was observed in 61% (67/110) of all treated sides. On Week 4, 8, and 16, hyperpigmentation was more developed in the 20%-ALA group than in the other two groups (p < 0.05). DISCUSSION: In terms of complete clearance rate, the 5% ALA-PDT group was significantly inferior to the 10% and 20% ALA-PDT groups at each follow-up. In contrast, the 20% ALA group showed a higher incidence rate of transient hyperpigmentation than the other two groups. CONCLUSIONS: This randomised clinical trial suggests that PDT with ALA of 10% concentration offers better efficacy and safety than 5% or 20% concentration for generalised recalcitrant facial verruca plana.
RCT Entities:
BACKGROUND: Generalised recalcitrant facial verruca plana responds poorly to current therapeutic options, including cryotherapy, topical drugs and carbon dioxide (CO2 ) laser. Case reports and uncontrolled studies suggested that topical photodynamic therapy (PDT) is effective choice of treatment free from potential complications associated with invasive therapies. AIMS: To investigate the efficacy and safety of PDT with different concentrations of photosensitiser in the treatment of verruca plana. MATERIALS & METHODS: The two sides of a subject's face were separately randomized to receive aminolevulinic acid (ALA) of 5%, 10% or 20% concentration. All patients were irradiated with 633-nm red light for 339 J/cm(2) total dose. Complete response (CR) rate was assessed on Week 4, 8, and 16 respectively. RESULTS: The mean overall clearance rate was 74.1%, 68.8%, and 64.6% on Week 4, 8, and 12, respectively, in the 110 treated sides. The CR rate was lower in the 5%-ALA group than in the 10%-ALA group (14.3% vs. 33.3%, p < 0.05) and 20%-ALA group (14.3% vs. 26.3%, p < 0.05) after 12 weeks. The mean severity of pain measured by visual analogue scale (VAS) scoring was 3.8 (range: 2 to 10, depending on the lesion location). The overall recurrence rate was 16.7% (4/24) on Week 12. Hyperpigmentation was observed in 61% (67/110) of all treated sides. On Week 4, 8, and 16, hyperpigmentation was more developed in the 20%-ALA group than in the other two groups (p < 0.05). DISCUSSION: In terms of complete clearance rate, the 5% ALA-PDT group was significantly inferior to the 10% and 20% ALA-PDT groups at each follow-up. In contrast, the 20% ALA group showed a higher incidence rate of transient hyperpigmentation than the other two groups. CONCLUSIONS: This randomised clinical trial suggests that PDT with ALA of 10% concentration offers better efficacy and safety than 5% or 20% concentration for generalised recalcitrant facial verruca plana.
Authors: Jace A Willis; Vsevolod Cheburkanov; Giulia Kassab; Jennifer M Soares; Kate C Blanco; Vanderlei S Bagnato; Vladislav V Yakovlev Journal: Appl Phys Rev Date: 2021-06 Impact factor: 19.162