Effectiveness and safety of 0.5% timolol solution in the treatment of pyogenic granuloma: A randomized, double-blind and placebo-controlled study

Abstract

Introduction: Pyogenic granulomas are benign vascular lesions of the skin and mucosa which are often a source of concern because of their recurrent bleeding even with minimal trauma. Current treatment for pyogenic granuloma is ablative; no medical therapy is standardized to date. Timolol, due to its vasoconstrictive effect, vascular growth factor inhibition and apoptosis promotion properties, is a potential therapeutic option. Objectives: To assess the effectiveness and safety of topical timolol in the treatment of pyogenic granulomas. Methods: A two-centre, double-blind and placebo-controlled trial (Registration CTRI/2019/04/018581) was conducted. Patients of either sex were recruited with pyogenic granuloma lesions of less than eight weeks duration. Topical treatment with 0.5% timolol or matching glycerin placebo was continued for six weeks. Changes in color, size, bleeding tendency, physicians’ and patients’ global assessments and adverse events were assessed. Results: Forty subjects were randomized between the two groups which were comparable in age, sex, duration of illness and baseline lesion size.Significant improvement was noted with timolol, with color change from first follow-up onwards and lesion size reduction from second follow-up onward. Patients’ assessment of bleeding tendency also showed imrovement from the second visit onward. Between-group comparison showed significant difference with respect to percentage reduction in size (timolol 40.9%, placebo 3.4%; P = 0.002). Rescue treatment (electrosurgery) was required in five patients on placebo and in one in the timolol group (P = 0.182). Complete resolution occurred in 2 (10%) patients with timolol and in no patients on placebo (P = 0.231). Limitations: We observed effects of treatment for only six weeks. Conclusion: Topical timolol may be a treatment option for early pyogenic granulomas but complete resolution is unlikely in six weeks. Studies of longer duration are required to assess resolution and recurrence rates.

23-Year-old male with multiple giant facial pyogenic granulomas being treated with combined topical timolol and steroid: A case report

“…Topical corticosteroids affect the pathogenesis of PG in several ways, including vasoconstriction and inhibiting proangiogenic agents. β-blockers effectiveness was reported in terms of solitary PG lesions regression [ 12 ]. Although β-blockers have a gradual effect in treating PGs and the period of treatment would take more than 6 weeks, it can avoid the adverse effects of other treatments including scar formation [ 17 ].…”

“…Although surgical excision is the first-line treatment [ 1 ], many PG cases regress spontaneously upon follow-up only, with mild chances of scars formation [ 11 ]. Therefore, recent studies suggested a 6 weeks follow-up protocol alongside the appliance of topical β-blockers [ 12 ]. A recent review also suggested topical steroids and timolol as an efficient treatment, especially in cases of young ages and sites of cosmetic issues [ 13 ].…”

Authors’ reply

“…We thank the readers of our article 1 for going through it in detail and for including it in a journal club discussion. 2 The primary conclusions of our study were:…”

A case of multiple pyogenic granulomas of the trunk successfully treated with topical β‐blockers

“…6 Barry et al 6 early PG with a greater vascular component. 7 Some authors suggest that small PGs (<4 mm) may also respond favorably to the topical therapy. 6 However, according to Patra et al, 7 the percentage reduction in size showed no correlation with baseline size of the lesion and duration of the lesion.…”