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Thermoresponsive Hydroxybutyl Chitosan-Assisted Carteolol Delivery with Pulsed Dye Laser for Superficial Infantile
ZeHui Chen1, YiYan Tang1, MeiLian Zheng1
1Department of Plastic and Aesthetic Surgery, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian, People's Republic of China.
Purpose:
To preliminarily evaluate a thermoresponsive hydroxybutyl chitosan (HBC)-assisted topical carteolol delivery regimen combined with pulsed dye laser (PDL), compared with conventional carteolol wet-compress therapy combined with PDL, in infants with superficial infantile hemangiomas.
Patients And Methods:
This single-center, open-label, randomized exploratory study included 40 infants with superficial IHs, who were assigned to an HBC group or a control group at a 1:1 ratio. Both groups received PDL. The HBC group received immediate post-laser topical application of the optimized HBC-carteolol mixture, whereas the control group received conventional topical carteolol wet-compress therapy after PDL. The predefined efficacy assessment was performed at the 6-month visit, while clinical follow-up continued for 6 to 12 months as routine clinical follow-up. The primary endpoint was the number of PDL treatment sessions completed during the 6-month treatment period. Secondary outcomes included 6-month Hemangioma Activity Score (HAS), change in HAS from baseline to 6 months, and treatment-related complications.
Results:
At the predefined 6-month assessment, the HBC group required fewer treatment sessions than the control group during the 6-month treatment period (3.5 ± 0.6 vs 4.7 ± 0.7, P < 0.001). The 6-month HAS was numerically lower in the HBC group than in the control group, but the difference was not statistically significant (0.3 ± 0.4 vs 0.4 ± 0.4, P = 0.272). The HAS change score also did not differ significantly between groups (4.6 ± 0.5 vs 4.5 ± 0.5, P = 0.440). The aggregate treatment-related local complication rate was lower in the HBC group than in the control group (5.0% vs 35.0%, P = 0.048).
Conclusion:
In this single-center exploratory randomized study, the HBC-carteolol-PDL regimen was associated with fewer treatment sessions and complications than conventional carteolol wet-compress therapy combined with PDL. Further component-controlled studies are needed to determine the independent effect of HBC.
