Assessing the effectiveness of topical betamethasone to treat chronic chilblains: a randomised clinical trial in primary care

Abstract

BackgroundGPs prescribe topical corticosteroids to patients with chronic chilblains despite poor evidence for their effectiveness. The authors of the current study therefore decided to assess the effectiveness of topical steroids in a primary care setting.AimTo assess the effectiveness of topical application of betamethasone valerate 0.1% cream in patients with chronic chilblains.Design and settingA placebo-controlled, double-blind, crossover, randomised clinical trial in a Dutch primary care setting.MethodThe study population consisted of 34 participants suffering from chronic chilblains. Intervention was topical application of betamethasone valerate 0.1% cream twice a day for 6 weeks compared with placebo. Primary outcome was the visual analogue scale on complaints (VOC). Secondary outcome was the visual analogue scale on disability (VOD). Both were assessed with a diary of daily scores on a 100 mm visual analogue scale. The authors took ambient temperatures into account, checked for a carry-over effect, performed additional analysis, and monitored adverse effects.ResultsOn the primary outcome mean VOC, there was a difference of 0.56 mm (95% confidence interval [CI] = −2.88 to 3.99 mm) in favour of placebo (P = 0.744). On the secondary outcome mean VOD, there was a difference of 0.88 mm (95% CI = −2.22 to 3.98 mm) in favour of placebo (P = 0.567). This study found no carry-over effect and no adverse effects.ConclusionIn this study, topical betamethasone was not superior to placebo in the treatment of chronic chilblains. Topical betamethasone should not be used for chronic chilblains without new evidence.

Chilblains

“…Although often used, the effect of topical betamethasone remains controversial. In a randomized trial of 34 patients (betamethasone valerate 0.1 % twice daily) for six weeks compared with placebo, there was no significant difference in symptoms between the two groups [60]. In their literature review, the Mayo Clinic shows a benefit of topical corticosteroid in 6 out of 8 patients [4].…”

Pharmacologic Treatment of Idiopathic Chilblains (Pernio): A Systematic Review

“…18 In March 2017, Souwer et al assessed the efficacy of twice daily application of topical betamethasone valerate 0.1% cream for 6 weeks to treat chilblains, but no clinically or statistically significant differences were found when compared to the placebo. 19 …”

“…The two remaining studies included in our review were high quality placebo-controlled double-blind randomized trials of topical corticosteroids and vitamin D. 19 , 20 None of these treatments showed superiority compared to placebo.…”

“…1,2 There have been cases of familial clustering, and a case-control series showed a familial relative risk of 3.6, suggesting genetic predisposition. 3,4 Chilblains-like presentations have been observed in patients testing positive for coronavirus disease 2019 (COVID- 19), although thought to occur through a different pathomechanism. 5 The typical presentation of idiopathic chilblains involves single or multiple symmetrically distributed, erythrocyanotic lesions on the distal toes and fingers, and less commonly the heels, nose, and ears.…”

Approach to Chilblains During the COVID-19 Pandemic

“…Though a moderate potency TCS was ineffective in a clinical trial for chronic chilblains, it is possible that the mechanism for chronic disease is different and that the moderate-potency TCS tested was not strong enough. 65 The second-line therapy for chilblains is a calcium channel blocker such as oral nifedipine: a double-blind, placebocontrolled trial found this drug to be efficacious for the treatment of chilblains. 66 The usual dosing is nifedipine 10 mg po TID with titration.…”