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 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 ( = 0.223, = 0.123, = 0.123, = 0.123, and = 0.103). At the end of the 96 week, both treatments achieved an excellent response ( = 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.