Vena G A, Cassano N, D'Argento V, Milani M
MIDIM Department, 2nd Dermatology Clinic, University of Bari, Bari, Italy.
Br J Dermatol. 2006 Feb;154(2):353-6. doi: 10.1111/j.1365-2133.2005.06986.x.
Delayed pressure urticaria (DPU) is characterized by the appearance of typical painful skin lesions (weals) after pressure stimulus. Oral corticosteroids are effective treatments but long-term therapy is problematic. A new topical formulation of clobetasol propionate 0.05% in thermophobic foam (CF) (Olux) has recently become available. The foam is easy to apply, with low skin residues.
To evaluate in a double-blind placebo-controlled trial the efficacy, tolerability and safety of CF in the topical treatment of DPU.
Twenty-six subjects with a positive history of DPU (13 men, mean age 44 years) were enrolled in a 4-week trial. CF or the corresponding placebo were applied twice daily. Drug application was performed in the most affected areas and in a target area where a standardized pressure challenge test was performed at baseline and at week 4. Efficacy was evaluated by scoring skin lesions regarding erythema, oedema and itching (0, no sign; 4, severe signs) and by calculating the area of the pressure challenge-induced lesion. Safety was evaluated by measuring plasma levels of adrenocorticotropic hormone (ACTH) and cortisol.
CF significantly (P = 0.0001) reduced lesion area by 84% in comparison with baseline values and by 97% in comparison with the placebo group values. Lesion area in the CF group was reduced from 144 cm(2) to 21 cm(2) at the end of the study. No significant differences in lesion area and clinical lesion scores were observed in the placebo group (lesion area 201 cm(2) at baseline; 216 cm(2) after 4 weeks). A significant clinical improvement was observed in all treated skin areas in the CF group. Mean +/- SD erythema score was reduced by CF from 1.8 +/- 0.6 at baseline to 0.6 +/- 0.5 at the end of the treatment (P = 0.001). Similar modifications were observed also for oedema (from 1.6 +/- 0.6 to 0.2 +/- 0.5) and itching score. Nonsignificant modifications of plasma levels of ACTH, cortisol and glucose were observed in both study groups, in comparison with baseline values. No adverse events were recorded during the trial in either treatment group.
CF is effective, safe, convenient and well tolerated in the short-term treatment of DPU.
迟发性压力性荨麻疹（DPU）的特征是在压力刺激后出现典型的疼痛性皮肤损害（风团）。口服糖皮质激素是有效的治疗方法，但长期治疗存在问题。一种新的0.05%丙酸氯倍他索热感泡沫制剂（CF）（Olux）最近已上市。该泡沫易于涂抹，皮肤残留量低。
在一项双盲安慰剂对照试验中评估CF局部治疗DPU的疗效、耐受性和安全性。
26名有DPU阳性病史的受试者（13名男性，平均年龄44岁）参加了一项为期4周的试验。CF或相应的安慰剂每天涂抹两次。在最受影响的区域以及在基线和第4周进行标准化压力激发试验的目标区域涂抹药物。通过对皮肤损害的红斑、水肿和瘙痒进行评分（0分，无体征；4分，严重体征）以及计算压力激发引起的损害面积来评估疗效。通过测量血浆促肾上腺皮质激素（ACTH）和皮质醇水平来评估安全性。
与基线值相比，CF显著（P = 0.0001）使损害面积减少了84%，与安慰剂组值相比减少了97%。在研究结束时，CF组的损害面积从144 cm²降至21 cm²。安慰剂组的损害面积和临床损害评分无显著差异（基线时为201 cm²；4周后为216 cm²）。CF组所有治疗的皮肤区域均观察到显著的临床改善。CF使平均±标准差红斑评分从基线时的1.8±0.6降至治疗结束时的0.6±0.5（P = 0.001）。水肿（从1.6±0.6降至0.2±0.5）和瘙痒评分也有类似变化。与基线值相比，两个研究组的ACTH、皮质醇和葡萄糖血浆水平均无显著变化。在试验期间，两个治疗组均未记录到不良事件。
CF在DPU的短期治疗中有效、安全、方便且耐受性良好。
