Efficacy and Safety of Fractional CO(2) Laser Combined with Halometasone Cream for Treatment of Moderate-to-Severe Chronic Hand Eczema: A Prospective, Single-Center, Parallel-Group, Open-Label Randomized Trial

INTRODUCTION: The purpose of this study was to assess the efficacy and safety of fractional CO(2) laser combined with halometasone cream in patients with moderate-to-severe chronic hand eczema (CHE). METHODS: A prospective, single-center, parallel-group, open-label randomized trial including 67 patients with moderate-to-severe CHE was carried out. Patients were randomly assigned to group A (n = 33, fractional CO(2) laser once every 4 weeks 1–2 times and halometasone cream twice daily for 8 weeks) or group B (n = 34, halometasone cream alone twice daily for 8 weeks). The primary endpoint was the proportion of patients achieving treatment success at week 12 in each group. Secondary endpoints included differences between groups in the change of hand eczema severity index (HECSI), patient global assessment (PaGA), dermatology life quality index (DLQI), and quality of life in hand eczema questionnaire (QOLHEQ) from baseline to week 12. Relapse rate and adverse effects were also recorded. RESULTS: A total of 29 patients in each group completed the trial. At week 12, the treatment success rate was 62.1% (18/29) in group A and 27.6% (8/29) in group B (p = 0.009). At week 12, HECSI, PaGA, DLQI, and QOLHEQ all decreased compared with baseline in both groups (p < 0.05). HECSI, DLQI, and QOLHEQ decreased more in group A than group B (p = 0.014, 0.010, and 0.014, respectively), but there was no significant difference in change of PaGA between the two groups (1.0 versus 3.0, p = 0.419). Among patients achieving treatment success, 11.1% (2/18) patients in group A and 50.0% (4/8) patients in group B relapsed at week 24 (p = 0.011). Skin pigmentation was the most common adverse effect. CONCLUSIONS: For patients with moderate-to-severe CHE, fractional CO(2) laser combined with halometasone cream is more effective than halometasone cream alone, with few adverse effects. TRIAL REGISTRATION NUMBER: ChiCTR2100051948.