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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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2025-05-01
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| Series: | Journal of Indian Association of Pediatric Surgeons |
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| Online Access: | https://journals.lww.com/10.4103/jiaps.jiaps_256_24 |
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| author | Sunita Singh Niraj Kumar Srivastava Amrita Upadhyaya Mrityunjay Kumar Neeraj Pawar Rohit Kapoor |
| author_facet | Sunita Singh Niraj Kumar Srivastava Amrita Upadhyaya Mrityunjay Kumar Neeraj Pawar Rohit Kapoor |
| author_sort | Sunita Singh |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-1d00e24b7e6d48b9b2c5e5f168a88c6d |
| institution | Kabale University |
| issn | 0971-9261 1998-3891 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Journal of Indian Association of Pediatric Surgeons |
| spelling | doaj-art-1d00e24b7e6d48b9b2c5e5f168a88c6d2025-08-20T03:48:52ZengWolters Kluwer Medknow PublicationsJournal of Indian Association of Pediatric Surgeons0971-92611998-38912025-05-0130330831610.4103/jiaps.jiaps_256_24Efficacy of 0.5% Timolol Maleate versus 0.05% Clobetasol Propionate in Treating Superficial Infantile Hemangioma: A Pilot Randomized Controlled TrialSunita SinghNiraj Kumar SrivastavaAmrita UpadhyayaMrityunjay KumarNeeraj PawarRohit KapoorAim: 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.https://journals.lww.com/10.4103/jiaps.jiaps_256_240.05% clobetasol propionate0.5% timolol maleatebenign vascular tumorhemangiomainfantile hemangiomasuperficial infantile hemangiomatopical steroidvascular malformation |
| spellingShingle | Sunita Singh Niraj Kumar Srivastava Amrita Upadhyaya Mrityunjay Kumar Neeraj Pawar Rohit Kapoor Efficacy of 0.5% Timolol Maleate versus 0.05% Clobetasol Propionate in Treating Superficial Infantile Hemangioma: A Pilot Randomized Controlled Trial Journal of Indian Association of Pediatric Surgeons 0.05% clobetasol propionate 0.5% timolol maleate benign vascular tumor hemangioma infantile hemangioma superficial infantile hemangioma topical steroid vascular malformation |
| title | Efficacy of 0.5% Timolol Maleate versus 0.05% Clobetasol Propionate in Treating Superficial Infantile Hemangioma: A Pilot Randomized Controlled Trial |
| title_full | Efficacy of 0.5% Timolol Maleate versus 0.05% Clobetasol Propionate in Treating Superficial Infantile Hemangioma: A Pilot Randomized Controlled Trial |
| title_fullStr | Efficacy of 0.5% Timolol Maleate versus 0.05% Clobetasol Propionate in Treating Superficial Infantile Hemangioma: A Pilot Randomized Controlled Trial |
| title_full_unstemmed | Efficacy of 0.5% Timolol Maleate versus 0.05% Clobetasol Propionate in Treating Superficial Infantile Hemangioma: A Pilot Randomized Controlled Trial |
| title_short | Efficacy of 0.5% Timolol Maleate versus 0.05% Clobetasol Propionate in Treating Superficial Infantile Hemangioma: A Pilot Randomized Controlled Trial |
| title_sort | efficacy of 0 5 timolol maleate versus 0 05 clobetasol propionate in treating superficial infantile hemangioma a pilot randomized controlled trial |
| topic | 0.05% clobetasol propionate 0.5% timolol maleate benign vascular tumor hemangioma infantile hemangioma superficial infantile hemangioma topical steroid vascular malformation |
| url | https://journals.lww.com/10.4103/jiaps.jiaps_256_24 |
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