An observer blinded randomised controlled pilot trial comparing localised immersion psoralen ultraviolet A (PUVA) with localised narrowband ultraviolet B (NBUVB) for the treatment of palmar hand eczema

Summary

Background

Hand eczema is a common inflammatory dermatosis that causes significant patient morbidity. Symptoms such as pain, itch and localised swelling contribute to disruption of activities of daily living, lack of sleep, and missed days from work. The aetiology is often multifactorial. Previous studies comparing psoralen ultraviolet A (PUVA) and narrowband ultraviolet B (NBUVB) have been small, non-randomised and retrospective.

Objectives

To conduct an observer blinded randomized controlled pilot study using validated scoring criteria to compare immersion PUVA with NBUVB for the treatment of chronic hand eczema unresponsive to topical steroids.

Methods

60 patients (22 male, 38 female), median age 50 years (range 22, 73), with hand eczema unresponsive to clobetasol propionate 0.05% (Dermovate^®) (25 (42%) severe), were randomised to receive either immersion PUVA (n=30) or NBUVB (n=30) twice weekly for 12 weeks with assessments at intervals of 4 weeks. The primary outcome measure was the proportion of patients achieving a 'clear' or 'almost clear' Physician's Global Assessment (PGA) treatment response at 12 weeks. Secondary outcome measures included assessment of the modified Total Lesion and Symptom Score (mTLSS) and the Dermatology Life Quality index (DLQI).

Results

In both treatment arms, 23 patients completed the 12-week assessment for the primary outcome measure. In the PUVA group, 5 patients achieved 'clear', and 8 'almost clear' (ITT response rate 43% (95%CI: 26%, 61%)). In the NB-UVB group, 2 achieved 'clear' and 5 'almost clear' (ITT response rate 23% (95%CI: 8%, 38%)). For the secondary outcomes, median (IQR) mTLSS scores were similar between groups at baseline (PUVA 9.5 (6.8,11), NBUVB 9 (6.8,12)) and at 12-weeks (PUVA 3 (1,6), NBUVB 4(2,8)). Changes in DLQI were similar with improvements in both groups.

Conclusions

In this randomised pilot trial recruitment was challenging. Once randomised, there were acceptable levels of compliance and safety in each treatment schedule, but lower levels of retention. Using validated scoring systems; PGA, mTLSS and DLQI as measures of treatment response, the trial demonstrated that both PUVA and NBUVB improved the severity of chronic palmar hand eczema. The study was not designed to demonstrate superiority of one treatment and a larger adequately powered RCT will be required to investigate this.

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