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1.
J Dermatolog Treat ; 14(2): 71-85, 2003 Jun.
Article in English | MEDLINE | ID: mdl-12775314

ABSTRACT

Topical steroid creams and ointments have been available as over-the-counter (OTC) medications for the self treatment of acute dermatitis and other steroid responsive skin disorders for more than ten years. Despite earlier fears, widespread availability and use of these creams is not associated with clinically significant adverse effects. In dermatological practice, hydrocortisone 1% remains the mainstay of treatment for facial eczema, but it is often not effective in eczema affecting other body areas. Eumovate(TM) (clobetasone butyrate 0.05%) cream has recently been made available as a pharmacy medication for the short-term management of acute eczema and allergic dermatitis by adults and children aged 10 or older, based on evidence derived from clinical trials involving over 3500 patients. This review summarises the key efficacy and safety data derived from 29 clinical trials and the post-licensing pharmacovigilance safety information, which supported the reclassification of this product for OTC use. These data show clobetasone butyrate 0.05% is more effective than 1.0% hydrocortisone in the treatment of eczema and more effective than flurandrenolone 0.0125% (p=0.01%) and a potent topical steroid hydrocortisone butyrate (p<0.05), in the treatment of psoriasis. A review of the effect of topical steroids on skin thickness concluded that, following short term application, there was no clinically significant difference between hydrocortisone 1.0% and clobetasone butyrate 0.05% in terms of potential for skin thinning. Similarly, even under extreme conditions, clobetasone butyrate 0.05% has negligible systemic absorption and has almost no effect on HPA axis function.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Clobetasol/analogs & derivatives , Clobetasol/therapeutic use , Dermatitis/drug therapy , Acute Disease , Administration, Cutaneous , Administration, Topical , Adverse Drug Reaction Reporting Systems , Anti-Inflammatory Agents/administration & dosage , Anti-Inflammatory Agents/adverse effects , Clobetasol/administration & dosage , Clobetasol/adverse effects , Dermatitis/pathology , Humans , Hydrocortisone/administration & dosage , Hydrocortisone/therapeutic use , Nonprescription Drugs , Ointments , Randomized Controlled Trials as Topic , Self Medication
2.
J Dermatolog Treat ; 12(4): 191-7, 2001 Dec.
Article in English | MEDLINE | ID: mdl-12241627

ABSTRACT

BACKGROUND: The emollient base of a topical corticosteroid, through its moisturizing properties, can be a useful treatment adjunct. OBJECTIVE: To compare the healing properties of Eumovate trade mark (clobetasone butyrate) 0.05% cream with its emollient base, hydrocortisone 1% cream and with no treatment. METHODS: A single-centre, double-blind, intra-individual, comparative study that involved 18 volunteers with nickel-induced contact dermatitis. Following a positive patch test to nickel, sub-therapeutic amounts (10 micro l = 3 mg cm(-2)) of each of the treatments were applied twice daily for seven days to each of the four test sites. RESULTS: In terms of the primary endpoint, a physician's global assessment after 7 days of treatment, clobetasone butyrate (CB) 0.05% cream showed a significantly better response than hydrocortisone (HC) 1% cream (78% vs 39%, difference -0.4, 95% CI -0.7 to -0.1; p = 0.046) or no treatment (78% vs 28%, difference -0.5, 95% CI -0.9 to -0.1; p = 0.016). CB 0.05% cream also showed a better response than its emollient base (78% vs 56%), though statistical significance was not achieved. In terms of moisturizing effects, there was no difference in transepidermal water loss (TEWL) between CB 0.05% cream and its emollient base. CB 0.05% cream treated sites did, however, have significantly lower values (i.e. were more moisturized) than untreated sites (difference -8.5, 95% CI -12.0 to -4.86; p < 0.001) or HC 1% treated sites (difference -7.1, 95% CI -11.0 to -3.4; p < 0.001). In terms of skin blanching activity, as expected the steroid-based creams achieved lower colorimetric values than the emollient base cream. CONCLUSIONS: These results from experimentally induced skin inflammation indicate that CB 0.05% (as Eumovate 0.05% cream) has both more effective anti-inflammatory activity and better moisturizing properties than hydrocortisone 1% cream and that these effects are in part due to its efficient emollient base.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Clobetasol/analogs & derivatives , Clobetasol/therapeutic use , Dermatitis, Contact/drug therapy , Nickel/adverse effects , Administration, Cutaneous , Administration, Topical , Adolescent , Adult , Analysis of Variance , Dermatitis, Contact/etiology , Double-Blind Method , Female , Humans , Hydrocortisone , Middle Aged , Ointments , Patch Tests , Treatment Outcome , Water Loss, Insensible/drug effects
3.
J R Soc Med ; 85(9): 530-3, 1992 Sep.
Article in English | MEDLINE | ID: mdl-1433118

ABSTRACT

Urgent treatment of serious infections with broad spectrum antibiotics usually starts before bacteriological evidence of the infective organism(s) becomes available. In this study 471 patients with a clinical diagnosis of sepsis were treated empirically with ceftazidime (CAZ) monotherapy (249 patients), or with an aminoglycoside+(ureido)penicillin combination (AG+PEN) (222 patients) to establish clinical outcome and bacteriological response. Up to 72 h post-treatment 94.5% of patients in the CAZ group and 93.8% in the AG+PEN group were treated successfully (treatment difference 0.7%, P < 0.01, 95% confidence interval -3.8%, 5.2%); 2-4 weeks after treatment neither regimen proved clinically superior. The differences in bacteriological response up to 72 h, and at 2-4 weeks after treatment, were 5.6% and 12.4% in favour of CAZ, however, these were not statistically significant. Overall, 56 patients reported 72 adverse events in the CAZ group, compared with 33 patients reporting 41 adverse events in the AG+PEN group. Deaths, 40 on CAZ and 21 on AG+PEN, were mainly related to their underlying condition. The two regimens were shown to be clinically equivalent in seriously ill patients treated empirically.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Bacterial Infections/drug therapy , Ceftazidime/therapeutic use , Penicillins/therapeutic use , Adult , Aged , Aminoglycosides , Anti-Bacterial Agents/adverse effects , Ceftazidime/adverse effects , Drug Therapy, Combination/adverse effects , Drug Therapy, Combination/therapeutic use , Female , Humans , Male , Middle Aged , Penicillins/adverse effects , Treatment Outcome
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