Author(s): Francesco Lacarrubba, Maria Letizia Musumeci, Massimo Milani and Giuseppe Micali
Background: Emollients and keratolytics creams with corticosteroids have been demonstrated to be useful in plaque psoriasis (PP), improving clinical response with a steroid-sparing effect. However, so far, no trials with objective measurement evaluations are available. Aim of this intra-patient randomized, assessor-blinded, 4-week study was to evaluate, by means of ultrasound imaging, the efficacy of the combination of hydrocortisone valerate 0.1% cream (HVC) once daily with an emollient, keratolytic, keratoplastic and anti-inflammatory cream (EKC) containing urea 20%, salicylic acid 2% and niacinamide (2%) once-daily vs. HVC alone applied twice-daily in PP.
Methods: Fifteen patients with mild-to-moderate PP were enrolled. For each patient two symmetrical, target lesions were selected and randomized to receive HVC+EKC or HVC alone for 4 weeks. Primary efficacy parameter was the reduction of skin thickness by ultrasound evaluation using a 22 MHz B-mode high-resolution system. Secondary endpoint was the assessment of Target Lesion Score (TLS) evaluating erythema, scaling, infiltration and itching with a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, 4=very severe).
Results: Twelve patients were randomised and concluded the trial. Combination therapy with HVC+EKC was as effective as corticosteroid twice-daily with a similar reduction of psoriatic skin thickness at week 4 in comparison with baseline (combination therapy: from 2.59 ± 0.4 mm at baseline to 2.19 ± 0.4 mm at week 4; mono-therapy from 2.56 ± 0.4 mm to 2.14 ± 0.37 mm). TLS reductions observed at the end of the study were similar in the two treatment regimens. Combination therapy (HVC+EKC) was as effective as mono-therapy (HVC) twice daily with a similar reduction, objectively evaluated, of skin thickness at week 4 in comparisons with baseline. The efficacy results were paralleled by the reduction of TLS.
Conclusion: Our results confirm that the concomitant use of emollients with topical corticosteroids is efficacious in plaque psoriasis, with a steroid-sparing effect.
