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At least 19 recordsLinked to original sources

Onset of the vasoconstrictor effect of diflucortolone valerate, betamethasone valerate, and fluocinolone acetonide ointments applied for varying periods under occlusive dressings.

Evaluation of cutaneous vasoconstriction after applications of varying duration of topical corticoids on the flexor surfaces of the forearms of 20 patients with intact skin shows a significantly faster blanching effect with diflucortolone valerate ointment than with fluocinolone acetonide and betamethasone valerate ointments. Furthermore, the test shows that even for a highly active preparation, such as the diflucortolone valerate ointment, an application time of less than 3 h only exceptionally leads to vasoconstriction in the healthy skin.

Administration, Topical↗

[Comparative studies in man on the percutaneous absorption of diflucortolone valerate, betamethasone-17-valerate, beclomethasone dipropionate and fluocinolone acetonide].

Percutaneous absorption of 6alpha,9-difluor-11beta-hydroxy-16alpha-methyl-21-valeryloxy-1,4-pregnadience-3,20-dione (diflucortolone valerate, DFV, Nerisona), betamethasone 17-valerate (BV), beclomethasone dipropionate (BDP) and fluocinolone acetonide (FA) by damaged skin was examined on the backs of 4 healthy males from whom the stratum corneum had been removed by "stripping". The determination of percutaneous absorption was performed on the one hand by a method employing radioactive labelled compounds (DFV, BV) and measuring the elimination with the urine and faeces and on the other hand by photometric determination (DFV, BV, BD, fa) of the corticoid remaining on the skin immediately following application and at the end of a 24-h period of exposure. Direct measurement of the radioactivity in the urine and faeces revealed that percutaneous absorption from a new W/O emulsion takes place up to 2.2+/-0.8% in the case of DFV (0.1%) and to at least 12.2+/-3.3% in the case of BV (0.12%) within 24 h. The determination of percutaneous absorption via recovery from the skin produced the following results for the 4 corticoid preparations examined: DFV (14.8+/-4.2%) and BDP (14.0+/-4.3%) approximately equal, BV (23.5+/-4.1%) a marked increase and FA (39.2+/-2.4%) the highest level of absorption. This order for percutaneous absorption appears to correlate to the frequency of systemic side effects.

Administration, Topical↗

Relationship between in vivo skin blanching and in vitro release rate for betamethasone valerate creams.

Betamethasone valerate creams from two firms were evaluated using the skin blanching procedure. In both studies, the same cream formulation exhibited significantly higher blanching compared to the other product. An in vitro release rate was determined for these betamethasone valerate cream products using a diffusion cell system, with a cellulose acetate membrane and a 60% ethanol:water receptor medium. The release rate (flux) of betamethasone valerate was higher for the higher blanching formulation and was statistically different from the other product. The integrity of the cellulose acetate membrane in 60% ethanol:water mixture was ascertained using hydrocortisone cream product. The in vitro drug release method, using a diffusion cell system and a synthetic membrane, can serve as a good quality control test method for topical creams.

Betamethasone Valerate↗

Efficacy of betamethasone valerate foam formulation in comparison with betamethasone dipropionate lotion in the treatment of mild-to-moderate alopecia areata: a multicenter, prospective, randomized, controlled, investigator-blinded trial.

BACKGROUND: Betamethasone valerate foam (BVF) is a new topical corticosteroid formulation. In scalp psoriasis patients BVF has induced a significantly greater clinical improvement in comparison with corticosteroid lotions. No data are available to date regarding the efficacy and safety of BVF in mild-to-moderate alopecia areata (AA). STUDY AIM: To evaluate the efficacy, tolerability and safety of BVF treatment in patients with mild-to-moderate AA. SUBJECTS AND METHODS: Sixty-one patients (26 men and 35 women; mean age 41 +/- 13 years) with mild-to-moderate AA (hair loss < 26%) were enrolled in a parallel-group, investigator-blinded trial. Subjects were assigned randomly to BVF (31 patients) or to betamethasone dipropionate lotion (BDL) (30 subjects). Both treatments were applied to the affected areas twice a day for 12 consecutive weeks. OUTCOMES: The primary study outcome was to compare the hair regrowth rate. Efficacy was evaluated at weeks 8 and 12 and at follow up (week 20), using a hair regrowth score (RGS) with a scale ranging from 0 (regrowth < 10%) to 4 (regrowth > 75%). RESULTS: Fifty-seven subjects (93%) completed the trial. At week 20, the RGS was 3.1 +/- 1.5 and 1.8 +/- 1.6 in the BVF and BDL groups, respectively (P < 0.01). A RGS > 3 was observed in 61% of patients in the BVF group (19/31) in comparison with 27% (8/30) in the BDL group (P < 0.03). No serious adverse events were observed in both groups during the study. CONCLUSION: Betamethasone valerate foam has shown to be an effective and well-tolerated treatment of mild-to-moderate AA. Further trials are warranted to evaluate the role of this new formulation in comparison or in combination with intralesional corticosterioids in AA treatment.

Administration, Topical↗

Betamethasone valerate in the treatment of summer hay fever.

Betamethasone valerate nasal aerosol in a daily dose of 400 micrograms was compared with a placebo in a double-blind trial involving 103 patients with summer hay fever. The patients' and physicians' preference for the active compound was statistically significant (P less than 0.001), with 88% of the patients receiving betamethasone valerate obtaining substantial relief of symptoms. The analysis of patients' daily symptom scores showed that nasal symptoms were significantly reduced by the active aerosol (P less than 0.001). A day-by-day comparison of nasal symptom scores with pollen counts indicated a decreasing allergic response as the season progressed; possible reasons for this are discussed. No clinically significant side effects were observed. Short tetracosactrin tests from ten randomly chosen patients on betamethasone valerate showed no abnormality and nasal swabs for Candida culture from a further thirty-two patients were negative. It is concluded that intranasal betamethasone valerate is an effective and safe form of therapy for seasonal rhinitis.

Administration, Intranasal↗

Intranasal betamethasone valerate in the treatment of seasonal rhinitis.

Betamethasone valerate aerosol given in doses of 100 mug into each nostril twice daily was compared with a placebo in a double-blind, cross-over trial involving thirty patients with seasonal rhinitis. Patients recorded symptoms of eye irritation and watering, sneezing, rhinorrhoea, and nasal blockage, on a diary card. Analysis of the symptom scores showed that nasal symptoms were significantly better on betamethasone valerate than on placebo (P less than 0.01) and that nasal blockage in particular was improved (P less than 0.001). The patients' preference was significantly in favour of the active compound (p less than 0.02) and no side-effects were noted. It is concluded that betamethasone valerate offers a safe and effective form of treatment for seasonal rhinitis.

Administration, Intranasal↗

[Betamethasone valerate reference standard (Control 941) of the National Institute of Health Sciences].

The raw material for betamethasone valerate was tested for preparation of the "Betamethasone Valerate Reference Standard (Control 941)". Analytical data obtained were as follows: melting point, 194.3 degrees C (decomposition); UV and infrared spectra, the same as those for JP Betamethasone Valerate Reference Standard (Control 844); optical rotation, [alpha]20D = +79.4 degrees; thin-layer chromatography and high-performance liquid chromatography (HPLC), no impurities were detected; assay, 100.0% by HPLC. Based on the above results, the candidate material was authorized as the JP Betamethasone Valerate Reference Standard (Control 941).

Betamethasone Valerate↗

Topical halcinonide and betamethasone valerate effects on plasma cortisol: acute and subacute usage studies.

The effect of topical application of halcinonide cream and betamethasone valerate cream on plasma cortisol was studied in an acute usage study as well as a subacute study, which more closely approximated common clinical usage. In the acute study, halcinonide cream caused a marked decrease in plasma cortisol, both with and without occlusion, in patients with extensive psoriasis, but only with occlusion in normal subjects. Betamethasone valerate cream decreased plasma cortisol levels in patients with extensive psoriasis when applied with occlusion and, to a lesser extent, without occlusion. In a double-blind subacute usage study without occlusion, two of 23 patients treated with halcinonide cream showed decreased plasma cortisol levels during the treatment period, while none of the 21 patients treated with betamethasone valerate cream showed such decreases. Three patients in the halcinonide group developed striae. Clinical response to halcinonide was superior to that with betamethasone valerate cream, but a similar number of patients were resistant to treatment with each medication.

Administration, Topical↗

Epidermal cytokeratin and immunocyte responses during treatment of psoriasis with calcipotriol and betamethasone valerate.

Changes in epidermal immunocytes and cytokeratins were investigated during treatment of psoriasis with calcipotriol and betamethasone valerate. Skin biopsies were obtained from 10 subjects on each treatment from lesional and non-lesional skin at baseline, and from treated lesions after 4 weeks. In each subject, changes in expression of cytokeratins K5, K10 and K16, and changes in epidermal immunocyte counts were assessed. Responses were compared with a separate histological parameter of improvement, epidermal thickness. Both treatments produced a marked normalization of cytokeratins. The reduction of K16 expression was similar on each treatment and correlated significantly with reduction in epidermal thickness. Expression of both K5 and K10 improved less than thickness with betamethasone valerate but more than thickness with calcipotriol, although these differences did not reach statistical significance. With calcipotriol there was an increase in K5 and K10 responses with increasing response of epidermal thickness, which was not seen with betamethasone valerate. T6+ cells, HLA-DR+ dendritic cells and T lymphocytes were all reduced by betamethasone valerate. There was a remarkable similarity in the level of normalization between cell types and also between cellular response and reduction in thickness. Calcipotriol produced a similar consistent reduction in cell numbers and in thickness, with the exception of T6+ cells which increased in some subjects during treatment. Only in subjects in whom thickness had virtually returned to normal was there a marked decrease in T6+ cells.

Adult↗

Effect of placebo substitution during long-term betamethasone valerate aerosol treatment in asthmatic children.

Ten children with severe asthma, who had been well controlled on maintenance betamethasone valerate aerosol for an average of 11 months, were given placebo aerosols without their knowledge. The period of placebo substitution was campared with one 28-day period of betamethasone valerate therapy beforehand, and two 28-day periods afterwards. Symptoms were increased during the placebo period, and patients did not return to their previous well-controlled state until the second month after reinstitution of therapy. Changes in the means of twice-daily peak expiratory flow readings (PEFR) followed the same pattern as changes in symptoms. The exacerbation of asthma which occurred during placebo treatment was accompanied by a widening in the diurnal variation between morning and evening PEFR. In comparison with the previous period, morning PEFR fell by a greater amount than evening PEFR. Standardized running tests suggest an increase in exercise-induced bronchoconstriction and in the Exercise Lability Index when the child was receiving only placebo treatment as compared with betamethasone valerate treatment. The trial provided further evidence of the efficacy of betamethasone valerate aerosol in the prophylatic therapy of severe childhood asthma. As 2 of these children were able to discontinue long-term therapy it is unlikely that this drug causes dependency.

Aerosols↗

Betamethasone valerate compared by the oral and inhaled routes in childhood asthma.

The value of betamethasone valerate by inhalation in the prophylactic therapy of severe childhood asthma has been established. To determine whether the efficacy of this drug is due to a local or a systemic action a double-blind crossover study of 28 days' treatment with oral betamethasone valerate and 28 days' treatment with inhaled steroid was carried out in 10 asthmatic children. Daily doses used were 1 mg orally and 800 mug by inhalation. Nine patients had fewer symptoms, higher peak expiratory flow rates, and a lower bronchodilator requirement on inhaled than on oral therapy. Exercise-induced bronchoconstriction was diminished on inhaled therapy. Five children requested early termination of the oral therapy period because of unacceptable symptoms. Nine parents stated a preference for the period of inhaled therapy. It is concluded that betamethasone valerate is highly effective by inhalation but that a comparable oral dose has no appreciable clinical effect.

Administration, Intranasal↗

Betamethasone valerate ointment compared with fluocinonide FAPG.

Betamethasone 0.1% as valerate in an ointment base and fluocinonide 0.05% in a fatty alcohol propylene glycol (FAPG) base have been compared in a double-blind trial of 76 patients with either eczema or psoriasis. The results show betamethasone valerate ointment to be significantly (P less than.05) superior to fluocinonide FAPG in the treatment of both these skin conditions. In the light of publications from other studies on betamethasone valerate cream this trial indicates that the ointment base considerably increases the efficacy of betamethasone valerate.

Betamethasone↗

A comparison of intranasal betamethasone valerate and sodium cromoglycate in seasonal allergic rhinitis.

A double-blind comparison of betamethasone valerate and sodium cromoglycate both given by the nasal route was carried out in forty patients with seasonal rhinitis caused by grass pollen. All patients kept daily symptom score cards, and half of them measured both oral and nasal peak expiratory flow rates twice daily. Adrenal function was monitored in thirty-one patients and found to be normal throughout. Sixteen of those patients receiving the steroid aerosol recorded success and two failure of treatment. By contrast, of those receiving sodium cromoglycate there were only two treatment successes and twelve failures. The total symptom score recorded in the group receiving betamethasone valerate was about half that recorded by the sodium cromoglycate group (P less than 0.01). No difference was observed between the two treatments in respect of nasal peak flow rate; specific IgE blood levels and weal sizes following prick tests were not significantly altered throughout the period of the trial, although total IgE was significantly increased. These results suggest that nasal betamethasone valerate offers patients with allergic rhinitis marked symptomatic benefit without the disadvantages previously associated with steroids.

Administration, Intranasal↗

Intranasal betamethasone valerate in seasonal rhinitis.

A double-blind study comparing betamethasone valerate and placebo aerosols was carried out in 40 patients with a history of seasonal allergic rhinitis and positive skin tests to grass pollens. Analysis of the symptoms recorded on a daily record card for a period of one month indicated that the mean monthly symptom-score was lower for all symptoms in the group on active therapy and that this reached statistical significance for the symptom of sneezing. Significantly more antihistamine tablets were used by the placebo group as compared with the active group (p less than 0-05). The patients' assessment of their treatment was in favour of betamethasone valerate (p less than 0-05). No clinically significant side-effects were associated with the treatment, which was well tolerated.

Administration, Intranasal↗

[Early effect of non-surgical treatment using betamethasone valerate ointment for phimosis in childhood].

We evaluated the early efficacy of non-surgical treatment using 0.07% betamethasone valerate ointment on, 34 boys with phimosis between January 2001 and June 2005. Patients were treated with 0.07% betamethasone valerate ointment applied to the distal aspect of the prepuce every other day for 2-6 weeks. During the treatment period, patients were instructed to retract the foreskin to penis root without overstraining. The overall success rate was 94.1% and therapeutic effects were observed in 58.8% of the patients in two weeks. There were no medical side effects. Treatment using betamethasone valerate ointment is very effective, easy and safe. We recommend this treatment for patients with phimosis and/or those with recurring balanoposthitis.

Anti-Inflammatory Agents↗

Comparative efficacy of once a day diflorasone diacetate and twice a day betamethasone valerate ointment applications in eczematous dermatitis.

The efficacy of once a day applications of 0.05% diflorasone diacetate ointment and twice a day applications of 0.1% betamethasone valerate ointment was compared in 70 patients with eczematous dermatitis. Altogether 32 patients completed the 3-week study. Fourteen patients in the diflorasone group and 6 on betamethasone left the study earlier because of total (100%) improvement of lesions. Eight patients left because of unsatisfactory progress and 6 because of personal reasons. There were only two noticeable differences observed between treatment groups. At Week 2, the diflorasone diacetate group improved significantly more than the betamethasone valerate group with respect to pruritus. At Week 3, this difference in the improvement of pruritus was marginally significant in favour of diflorasone diacetate. Excluding the complications due to a secondary infection, no adverse reactions were recorded in the diflorasone diacetate-treated patients; 1 betamethasone valerate-treated patient developed telangiectasia. The once a day applications of diflorasone diacetate not only proved to be slightly more efficacious than the twice a day applications of betamethasone valerate, but also provided the advantages of patient convenience and compliance.

Adolescent↗

A clinical study of the prophylactic use of betamethasone valerate and sodium cromoglycate in the treatment of seasonal allergic rhinitis.

The prophylactic use of betamethasone valerate and sodium cromoglycate in seasonal allergic rhinitis has been investigated in 20 patients in an open study. The subjective assessment of the symptoms recorded on a daily record card was significantly lower in the betamethasone valerate group compared with the sodium cromoglycate group. Patients' and physician's overall assessment of the treatment favoured the steroid aerosol. No clinically significant side effects were noted.

Aerosols↗