clobetasol and Urticaria

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.

Topics: Administration, Cutaneous; Adrenocorticotropic Hormone; Adult; Anti-Inflammatory Agents; Clobetasol; Double-Blind Method; Female; Humans; Hydrocortisone; Male; Middle Aged; Pressure; Skin Tests; Treatment Outcome; Urticaria

Very few studies have been conducted to assess the effect of corticosteroid application frequency to attain maximum benefit with minimum side-effects.. Compare the efficacy of twice-daily, once-daily and alternate-day applications of clobetasol propionate (0.05%) and compare whether an initial once-daily application followed by a subsequent alternate-day application is as effective as a once-daily application.. The ability of corticosteroids to suppress histamine-induced wheals on human skin was used as a human bioassay model. Of the 26 subjects included, 21 completed the 1st phase. In the 2nd phase, 11 subjects were included and all completed the study. Four sites were chosen on the left forearm. Clobetasol propionate (0.05%) was applied twice daily, once daily, and on alternate days, and on the control site a color, texture and odour-matched vehicle was applied. Prick test with histamine was carried out after 10 days. In the 2nd phase, clobetasol propionate (0.05%) was applied once daily for 14 days and compared with the initial once daily for 7 days and the subsequent alternate-day application for 7 days. Prick test was carried out after 14 days.. The once-daily application of clobetasol propionate (0.05%) was as effective as the twice-daily application, but the alternate-day application was less effective than the once-daily application (P < 0.01). Also, the initial-daily and subsequent alternate-day applications were not as effective as the continuous once-daily application (P < 0.05).. A once-daily application of clobetasol propionate (0.05%) is likely to provide the required therapeutic effect.

Topics: Administration, Cutaneous; Clobetasol; Drug Administration Schedule; Glucocorticoids; Histamine; Humans; Treatment Outcome; Urticaria

Twenty-three patients with chronic idiopathic urticaria and 3 patients with urticaria pigmentosa received a 2-week treatment with daily application of potent topical steroid using plastic occlusion. Seventy per cent of the chronic urticaria patients had a statistically significant, immediate response, which, however, did not last until the final evaluation after 1.5 years. Relapse occurred after on average 3 weeks, but 39% reported less severity. The 3 patients with urticaria pigmentosa remained free from attacks for 6 to 9 months, after which they gradually relapsed. Two women were diagnosed during the follow-up period to have a carcinoma of the breast, and one patient developed systemic lupus erythematosus.

Topics: Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents; Breast Neoplasms; Chronic Disease; Clobetasol; Female; Follow-Up Studies; Glucocorticoids; Humans; Lupus Erythematosus, Systemic; Male; Middle Aged; Occlusive Dressings; Recurrence; Retrospective Studies; Single-Blind Method; Surveys and Questionnaires; Treatment Outcome; Urticaria; Urticaria Pigmentosa

Six patients with delayed pressure urticaria (DPU) applied clobetasol propionate (0.05%) ointment or its base to predetermined test sites on the right and left thigh as part of a randomized, double-blind study. A pressure challenge was administered to each test site at the initial visit and repeated after 3 days and 6 weeks of treatment and at between 4 and 8 weeks after treatment. The areas of pressure-induced weals were measured 6 h after each challenge. At the 6-week visit, a 4-mm punch biopsy was taken from pressure-challenged skin on each test site. Sections were stained for mast cells and immunohistochemical labelling was used to demonstrate neutrophils (neutrophil elastase), eosinophils (eosinophil cationic protein), monocytes/macrophages (EBM 11), cells expressing the beta-2 integrins (CD11/18) and the vascular adhesion molecules, E selectin and intercellular adhesion molecule-1 (ICAM-1). In the steroid-treated sites, there was a significant decrease (P < 0.05, Wilcoxon's matched-pairs test) in the size of the pressure weals compared with baseline at 3 days, 6 weeks and at follow-up. Demonstrable mast cells were significantly decreased (P = 0.059) in the pressure-challenged areas in the steroid-treated sites compared with the base-treated sites. The histological response to pressure was minimal in both sites perhaps demonstrating an active pharmacological effect of the ointment base. In conclusion, the application of potent topical steroids significantly reduced the clinical response to pressure in patients with DPU, possibly through a reduction in mast cells.

Topics: Administration, Topical; Adult; Cell Adhesion Molecules; Cell Count; Clobetasol; Double-Blind Method; E-Selectin; Endothelium, Vascular; Female; Humans; Intercellular Adhesion Molecule-1; Male; Mast Cells; Middle Aged; Pressure; Urticaria

Clobetasol propionate 0.05% ointment and an otherwise identical steroid-free base were applied topically to a 10 cm2 area on the anterior thighs of six patients with symptomatic dermographism for 6 weeks. Four patients showed a significantly decreased wealing response to stroking of steroid pretreated skin compared to that of control sites. There was a parallel decrease in mast cell numbers and histamine levels in skin biopsies taken from the steroid treated areas. At 6 weeks two patients demonstrated a decrease in flare areas following the intradermal injection of compound 48/80 in steroid pretreated skin compared to base treated sites. Flare areas following intradermal injection of histamine in these two patients were equivalent in base and steroid treated skin.

Topics: Administration, Cutaneous; Adult; Betamethasone; Cell Count; Clobetasol; Female; Histamine; Humans; Male; Mast Cells; Middle Aged; Skin; Time Factors; Urticaria

Patients often tell about reduced effectiveness of topical steroids on repeated use. Tachyphylaxis to these agents has been demonstrated in humans for vasoconstriction and histamine-induced wheal suppression in normal skin, but not in diseased skin. Relevance of these data to diseased skin is not clear. Further, the clinical impression does not appear to match tachyphylaxis shown in normal skin with regard to the time course.. To examine whether tachyphylaxis to histamine-induced wheal suppression by a topical steroid occurs in dermatitic skin and to determine its time course vis-à-vis normal skin.. Pharmacodynamic response to 0.05% clobetasol propionate applied daily under occlusion was measured by histamine-induced wheal suppression assay in 10 individuals. This test was performed on a steroid-treated normal site, on a steroid-treated site where dermatitis was induced by occlusive application of 40% croton oil, and on a vehicle-treated site in each individual at different intervals up to 14 days.. Suppression of wheal volume started from second day in steroid-treated sites. There was significant difference in the wheal volume in steroid treated normal vs. dermatitic sites from day 2 to day 10. Maximum wheal suppression occurred earlier in dermatitic skin (day 4 vs. day 6). After this, the volume of wheal started increasing and became equal to control (complete tolerance) on 12th day in dermatitic skin and on 14th day in normal skin.. Time courses of tachyphylaxis to the action of 0.05% clobetasol propionate were significantly different in normal skin and dermatitic skin. Complete tolerance occurred earlier in dermatitic skin compared to normal skin.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Clobetasol; Croton Oil; Dermatitis, Contact; Glucocorticoids; Histamine; Humans; Irritants; Male; Skin; Tachyphylaxis; Urticaria