A randomized controlled clinical trial assessing the effect of betamethasone valerate 0.12% foam on the short-term treatment of stasis dermatitis

Abstract

Background: There are no published studies examining either the effectiveness of topical steroids in the treatment of stasis dermatitis or indicating what steroid strength or duration of treatment is optimal to treat this common condition.

Objective: To investigate the efficacy of twice-daily application of the topical steroid betamethasone valerate 0.12% foam for the treatment of stasis dermatitis.

Design: 42-day randomized, double-blinded, vehicle-controlled, pilot study.

Settings: Outpatient dermatology clinic at a university-affiliated clinic.

Subjects: 19 subjects, mean age of 73, with mild to moderate bilateral stasis dermatitis.

Intervention: Twice-daily application of betamethasone valerate 0.12% foam versus vehicle foam to bilateral randomly assigned lower legs for 28 days with follow-up to day 42.

Main outcome measures: The primary clinical endpoints were the mean change in erythema, scale, swelling, petechiae, post-inflammatory hyperpigmentation, and self-reported pruritus, assessed on a 5-point Likert scale (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe). Secondary endpoints were changes in health related quality of life (HRQL) using the EuroQol-5D (EQ-5D) utility score and visual analog scale (VAS) and the Dermatology Life Quality Index (DLQI).

Results: Although there was no overall difference between the foam and vehicle-treated leg at days 14 and 28, the steroid-treated leg, but not the vehicle-treated leg, showed statistical improvement over baseline. Improvement in the steroid-treated leg was statistically better than vehicle at days 14 and 28 in terms of erythema (P < .05) and petechiae (P < .05). Improvement in VAS was notable at days 14 (7.1%), 28 (9.7%), and 42 (9.6%) (P < .001). Similarly, there was a statistically significant improvement in the DLQI compared to baseline on visit days 14 (188.9%) and 28 (126.1%) (P < .001).

Conclusions: This study suggests that betamethasone valerate 0.12% foam is an effective and well-tolerated short-term treatment of stasis dermatitis, but that higher potency steroids may be needed to achieve better efficacy. Furthermore, these results are the first to suggest that the application of effective topical anti-inflammatory therapy can lead to improvement in HRQL.