Efficacy of 0.5% Timolol Maleate versus 0.05% Clobetasol Propionate in Treating Superficial Infantile Hemangioma: A Pilot Randomized Controlled Trial
Aim: To compare the efficacy of two topical agents in superficial infantile hemangioma (SIH). Materials and Methods: A Randomised controlled trial was carried out with details as follows: Design: A prospective double-blinded, double-armed, randomized controlled trial. Setting: Multidisciplinary unit...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer Medknow Publications
2025-05-01
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| Series: | Journal of Indian Association of Pediatric Surgeons |
| Subjects: | |
| Online Access: | https://journals.lww.com/10.4103/jiaps.jiaps_256_24 |
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| Summary: | Aim:
To compare the efficacy of two topical agents in superficial infantile hemangioma (SIH).
Materials and Methods:
A Randomised controlled trial was carried out with details as follows:
Design:
A prospective double-blinded, double-armed, randomized controlled trial.
Setting:
Multidisciplinary unit from 2022 to 2024.
Subjects:
Children younger than 2 years with color Doppler-confirmed SIH (superficial to deep dermal fascia).
Methods:
Randomization in treatment arm I: topical beta-blocker 0.5% timolol maleate (TTM) solution or treatment arm II: ultrapotent topical Steroid 0.05% clobetasol propionate ointment.
Outcome:
(1) reduction in area, (2) color change on visual analog scale (VAS), and (3) total VAS scores for color, size, and thickness. Each VAS parameter was rated from 0 to 3 (cumulative score 0–9).
Results:
Twenty patients were enrolled in each arm. Four patients in each group missed 96 weeks of follow up assessment but completed at least 9 months of treatment. In arm I, two patients were transitioned from TTM to oral propranolol due to rapid progression deep into the dermis. Arm I demonstrated a quicker improvement in color with a steeper reduction in area. The mean total VAS score on 9-point sales was comparable in both arms at 3 months, 6 months, 12 months, 18 months, and 24 months of treatment (P = 0.223, P = 0.123, P = 0.123, P = 0.123, and P = 0.103). At the end of the 96th week, both treatments achieved an excellent response (P = 0.634) with no rebound growth.
Conclusion:
0.5%-TTM solution can be a first-line therapy for SIH due to its rapid onset of action and overall comparable efficacy in reducing SIH size. While clobetasol remains effective, its slower response may limit its utility. |
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| ISSN: | 0971-9261 1998-3891 |