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At least 73 records · Page 4Linked to original sources
PubMed2000

Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. The European Tacrolimus Ointment Study Group.

OBJECTIVE: To investigate the safety and efficacy of using 0.1% tacrolimus ointment for long-term treatment of atopic dermatitis. DESIGN: Open-label, noncomparative study with 6 to 12 months of follow-up. SETTINGS: Outpatient departments in 30 study centers in 11 European countries. PATIENTS: We enrolled 316 patients aged 18 years and older with moderate to severe atopic dermatitis, 200 for 6 months and 116 for 12 months; 77.5% of patients completed the study. INTERVENTION: Twice-daily application of 0.1% tacrolimus ointment on all affected skin. Visits were scheduled on day 1; after 1, 2, and 4 weeks of treatment; and monthly thereafter. MAIN OUTCOME MEASURES: Safety assessments included monitoring of adverse events, clinical laboratory values, and tacrolimus blood concentrations. Efficacy end points included a combined score (modified Eczema Area and Severity Index) and an investigator's global assessment. RESULTS: Local irritation, adverse events such as burning sensation (47% of patients), pruritus (24% of patients), and erythema (12% of patients) were common but tended to occur only when initiating treatment. Laboratory values showed no marked changes over time. Systemic absorption was minimal, with the maximum tacrolimus blood concentration being less than 1 ng/mL in 76% of patients. All efficacy end points showed improvement. The mean (SD) modified Eczema Area and Severity Index score was 23.7 (12.6) at day 1, 13.5 (11.3) at week 1, 6.1 (9.2) at month 6, and 6.1 (8.1) at month 12. Marked or excellent improvement or clearance of disease was reported in 54%, 81%, and 86% of patients at week 1, month 6, and month 12, respectively. CONCLUSION: Up to 1 year of tacrolimus ointment use was safe and effective in patients with atopic dermatitis. Arch Dermatol. 2000;136:999-1006

Administration, Topical↗
PubMed1991

A double-blind, multicenter comparison of 0.05% halobetasol propionate ointment and 0.05% clobetasol propionate ointment in patients with chronic, localized plaque psoriasis.

In a double-blind, parallel-group, multicenter trial in 134 patients with severe, localized, plaque psoriasis, the success rate (described as "healed" or "marked improvement") at the end of the study was 96% in the halobetasol propionate group and 91% in the clobetasol propionate group. A significantly larger proportion of patients treated with halobetasol had no disease or mild disease after 14 days compared with those treated with clobetasol (86% versus 70%, p = 0.023). Healing within 24 days of starting treatment was noted in 69% and 56% of patients treated with halobetasol and clobetasol, respectively. Adverse effects were reported in a smaller percentage of patients treated with halobetasol propionate ointment than in those treated with clobetasol propionate ointment (7% versus 12%). Cosmetic acceptability and ease of application were recorded as "very good" in a larger percentage of patients treated with halobetasol propionate ointment than in the group treated with clobetasol propionate (90% versus 80%).

Adult↗
PubMed1991

A comparative, multicenter, double blind trial of 0.05% halobetasol propionate ointment and 0.1% betamethasone valerate ointment in the treatment of patients with chronic, localized plaque psoriasis.

In a double-blind, parallel-group, multicenter comparative trial in 84 evaluable patients with severe, localized plaque psoriasis, 0.05% halobetasol propionate ointment proved significantly superior (p = 0.02) to 0.1% betamethasone valerate ointment with respect to the success rate, as indicated by ratings of "healed" or "marked improvement" (88.1% versus 64.3%). The therapeutic effect was observed within 5 days of the start of treatment in 76% and 67% of the patients treated with halobetasol propionate and betamethasone valerate ointments, respectively. Both preparations were well tolerated. Minor adverse effects at the site of application were reported in only 2% of the patients in each treatment group. Neither skin atrophy nor systemic adverse effects were observed.

Adult↗
PubMed1992

Comparative study of calcipotriol (MC 903) ointment and betamethasone 17-valerate ointment in patients with psoriasis vulgaris.

BACKGROUND: Topical vitamin D analogues have been reported to be an effective treatment in patients with psoriasis. Comparative studies with existing treatments are required. OBJECTIVE: Our purpose was to compare the effectiveness of calcipotriol (50 micrograms/gm) and betamethasone 17-valerate (1 mg/gm) ointments twice daily in the treatment of stable plaque psoriasis. METHODS: This study was a randomized, double-blind comparison over 6 weeks in 409 patients. Efficacy, as measured by the Psoriasis Area and Severity Index (PASI), and safety were assessed at 2, 4, and 6 weeks. RESULTS: Reduction of PASI was statistically significant at all time points for both treatments but there were no significant between-treatment differences. At the completion of 6 weeks of treatment, the mean PASI reduction was 5.50 for calcipotriol and 5.32 for betamethasone (95% confidence interval [CI] -0.40 to 0.78). Analysis of patient assessment at 6 weeks showed clearance or marked improvement in 61.2% of the calcipotriol patients and 50.5% with betamethasone (95% CI 1.4 to 20.8). Calcipotriol produced significantly more local side effects (19.5% compared with 3.9%, p less than 0.001); however, these were minimal leading to withdrawal in only 3 of 205 patients. CONCLUSION: Calcipotriol ointment was as effective as betamethasone 17-valerate ointment as measured by the PASI and superior as measured by self-assessment in patients with stable plaque psoriasis. Both treatments were well tolerated.

Betamethasone Valerate↗
PubMed2005

Effects of calcipotriol cream and ointment, clobetasol cream and ointment and tretinoin cream on the erythemogenicity of UVB.

Various studies have shown the blocking effects of topical agents on UVB penetration, which can be used in combination with phototherapy. In this study, the photoprotective effects of 0.005% calcipotriol, 0.05% clobetasol-17-propionate, and 0.1% tretinoin, which can be used in combination with broad-band UVB, were investigated in an in vivo test. In a study group of 20 patients, phototests were performed to determine minimal erythema doses (MED) and the tests were repeated with thin (0.1 cc/25 cm2) and thick (0.3 cc/25 cm2) calcipotriol, clobetasol-17-propionate, and tretinoin in cream forms and sunscreen. After determining the MED, the test was repeated in another 20 patients with thin and thick calcipotriol and clobetasol-17-propionate in both cream and ointment forms and sunscreen. MED was increased with thin and thick applications of all agents. Moreover, the photoprotective effects of each agent increased with their thick applications compared with thin ones. The application of calcipotriol cream and ointment, clobetasol cream and ointment, and tretinoin cream, all of which can block UVB, is not recommended just before phototherapy.

Adult↗
PubMed1980

The efficacy of hydrocortisone in different ointment bases. A double-blind study of Hydroderm vs Hydrokortison ointments.

A study was designed to ascertain whether hydrocortisone 1% in a recently formulated ointment base was as efficacious as a well established hydrocortisone ointment formulation. There was no difference in the results of any observed parameter. It is condluded that Hydroderm ointment base is as good as previously used vehicles. It has the additional benefit of being hypoallergic.

Adolescent↗
PubMed1981

A double-blind trial of budesonide ointment and betamethasone-17-valerate ointment in psoriasis.

In a double-blind within-patient clinical trial in psoriasis, budesonide 0.025% ointment has been shown to be at least as efficient as betamethasone-17-valerate 0.1% ointment. A lower concentration of budesonide ointment, 0.01%, was used for 4 weeks of maintenance treatment. This concentration controlled residual symptoms well in a majority of the patients, thirty-two in number.

Adolescent↗
PubMed1986

A comparison of clobetasol propionate 0.05 percent ointment and an optimized betamethasone dipropionate 0.05 percent ointment in the treatment of psoriasis.

A multicenter, double-blind study compared the effectiveness of two highly potent topical corticosteroids in patients with moderate to severe signs of psoriasis. Left/right paired comparisons of clobetasol propionate ointment 0.05 percent, and an optimized formulation of betamethasone dipropionate ointment 0.05 percent, were made in 130 patients with roughly symmetrical psoriatic lesions. The ointments were applied by the patients twice daily, without occlusion, for two weeks. Both drugs were shown to be highly effective and were well tolerated. Significantly more patients showed greater improvement on the side treated with clobetasol propionate. Follow-up evaluation two weeks after the treatment period showed statistically significant (p less than 0.001) longer remissions resulting from the use of clobetasol propionate.

Administration, Topical↗
PubMed1985

Studies on the release of solubilized drugs from ointment bases. Part 9: Modelling of drug release process of active substance from emulsive ointments (W/O)--the mathematical model.

A new mathematical model of the release process of solubilized active substance from emulsive (W/O) ointments is proposed. This model is based on Fick's diffusion law and additional assumptions. The most important assumption is recognition of the heterogeneous character of emulsive ointments. An equation has been derived, which expresses the functional relationship between the quantity of substance liberated from the ointment and the period of release.

Emulsions↗
PubMed1985

Studies on the release of drugs from O/W emulsion ointments using the mathematical interpretations. Part 2: Influence of the ointment composition.

The empirical function Q = t/(A + Bt) has been applied to the quantitative description of the release process of salicylic acid from the emulsion ointment as influenced by its composition. The results as compared with those obtained by the use of Higuchi's "exponential" equation confirm the usefulness of the proposed equation, especially for thin ointment layers. It has been shown that there is a satisfactory correlation between the values of parameters 1/A, 1/B and thickness of the ointment layer and its composition. In this manner it is possible to predict the time course of the release process under other conditions.

Chemistry, Pharmaceutical↗
PubMed1984

[Comparison of the antiphlogistic effect of mucopolysaccharide-polysulfate ointments with heparin-containing ointments in the UV erythema test].

It could be demonstrated by means of the UV erythema model that four different ointment preparations containing mucopolysaccharide polysulfate (MPS) have a marked antiinflammatory effect and inhibit the formation of erythemas to a large extent. In this trial arrangement the different preparations containing MPS were significantly superior to altogether eight commercial heparin ointments, which were tested, too. With an inhibition of 69% of the erythema induced by UV rays, Hirudoid 40000 ointment is the most effective of all preparations tested.

Administration, Topical↗
PubMed1984

Studies on the efficacy and adrenal effects of Diprolene ointment 0.05 percent and Dermovate ointment 0.05 percent in patients with psoriasis or other resistant dermatoses.

The efficacy of Diprolene ointment 0.05 percent (betamethasone dipropionate in a glycol formulation) and Dermovate ointment 0.05 percent (clobetasone propionate) and their effects on adrenal function were evaluated in two double-blind, parallel group studies. A fixed dose of 7 gm of ointment a day was applied topically for fourteen days (Study 1) or twenty-one days (Study 2) to the skin of patients with psoriasis or other resistant dermatoses. To evaluate the adrenal effect of the treatments, plasma cortisol levels were determined for twenty of the sixty-one patients in Study 1 and for all of the twenty patients in Study 2. Efficacy and adverse experience data were evaluated for all patients. At the initial visit and at weekly follow-up visits, the selected lesions were graded for the severity of the signs and symptoms of disease. Most of the patients in these studies experienced a complete clearing of all the signs and symptoms of their disease by the end of the treatment with either Diprolene or Dermovate. The two treatments were equally effective. No adverse experiences were seen in the Diprolene group, but one patient with psoriasis in the Dermovate group had an exacerbation of the disease and the treatment was discontinued. In Study 1, reduction in plasma cortisol levels during treatment was observed in both groups, but to a distinctly lesser degree in the Diprolene than in the Dermovate group; levels below the normal range (184 to 767 nmol/l) were observed in one patient in the Diprolene group and in four patients in the Dermovate group.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1976

[Multicentre-clinical trial of the novel corticosteroid diflucortolone valerate in the forms of cream, ointment and fatty ointment. Part II: Comparative study with several commercial preparations (author's transl)].

6alpha,9-Difluoro-11beta-hydroxy-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione (diflucortolone valerate, Nerisona) in the forms of cream, ointment and fatty ointment was investigated against 5 commercial preparations with beta-methasone-17-valerate, fluocinonide, fluocinolone acetonide, flumetasone pivalate and desoximetasone in 15 simultaneously conducted and multicentre-clinical studies-all on double-blind contralateral studies-involving a total of 1923 patients. The Nerisona preparations proved to be highly effective-particularly in eczematous diseases- and comparable to the above-mentioned commercial preparations. Nerisona ointment was shown to be superior to flumetasone cream. The statistical reliability of such data is discussed.

Administration, Topical↗
PubMed1991

A double-blind, multicenter trial of 0.05% halobetasol propionate ointment and 0.05% clobetasol 17-propionate ointment in the treatment of patients with chronic, localized atopic dermatitis or lichen simplex chronicus.

In a double-blind, parallel-group, multicenter comparative trial in 127 evaluable patients with chronic, localized atopic dermatitis or lichen simplex chronicus, healing was reported in a higher percentage of patients treated with halobetasol propionate ointment than in those in the clobetasol propionate treatment group (65.1% versus 54.7%). The success rates (described as "healed" and "marked improvement") were practically identical in the two treatment groups (93.7% versus 92.2%). Early onset of therapeutic effect, that is, within 3 days of the start of treatment, was similar in the two treatment groups (24% versus 28%). Both preparations were well tolerated. Adverse effects were reported in 5% and 2% of the patients treated with halobetasol propionate and clobetasol propionate ointments, respectively.

Adolescent↗
PubMed1994

Comparative study of calcipotriene (MC 903) ointment and fluocinonide ointment in the treatment of psoriasis.

BACKGROUND: The topical vitamin D analogue calcipotriene has been reported to be an effective treatment for patients with psoriasis. Comparative studies with topical steroids are informative in judging this new therapy. OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of calcipotriene ointment 0.005% versus fluocinonide ointment 0.05% in the treatment of plaque psoriasis. METHODS: This study was a randomized, double-blind, parallel-group, active-controlled trial in adults who had at least mild overall disease severity and plaque elevation of at least moderate severity. Treatments were applied twice daily for 6 weeks, and subjects were evaluated at weeks 0, 2, 4, and 6. Subjects were graded on a 9-point scale (0 to 8) for scaling, erythema, plaque elevation, and for overall disease severity. A physician's global assessment of improvement/worsening was performed at every visit. RESULTS: A total of 114 subjects were enrolled at six study sites. Ninety-nine subjects completed the trial. Mean scores for signs of scaling and plaque elevation in calcipotriene-treated subjects were significantly lower by week 2 than in the fluocinonide-treated subjects. These scores continued to be significantly lower than fluocinonide through week 6 (p < 0.05). Mean scores for erythema in calcipotriene-treated subjects were significantly lower than those in fluocinonide-treated subjects at weeks 4 and 6 (p < 0.05). Both the physician's global assessment and overall disease severity showed statistically significant treatment differences in favor of calcipotriene at week 4 (p < 0.05). This superior efficacy continued through week 6. Treatment-related adverse events were observed in 12 calcipotriene-treated subjects and 5 fluocinonide-treated subjects; all were considered minor. CONCLUSION: Calcipotriene was superior to fluocinonide in the treatment of plaque psoriasis.

Adult↗
PubMed2004

A left/right comparison of twice-daily calcipotriol ointment and calcitriol ointment in patients with psoriasis: the effect on keratinocyte subpopulations.

Vitamin D3 analogues are a first-line treatment of chronic plaque psoriasis, but so far, comparative clinical studies on calcipotriol and calcitriol ointment are sparse, and in particular no comparative studies are available on cell biological effects of these compounds in vivo. Using flow cytometric assessment, we investigated whether these compounds had different effects on the composition and DNA synthesis of epidermal cell populations responsible for the psoriatic phenotype. For 8 weeks, 20 patients with psoriasis vulgaris were treated twice daily with calcipotriol and calcitriol ointment in a left/right comparative study. Before and after treatment, clinical assessment of target lesions was performed, together with flow cytometric analysis of epidermal subpopulations with respect to keratin (K) 10, K6, vimentin and DNA distribution. Treatment with each compound resulted in a substantial clinical improvement, a reduction of the K10-K6- population and an increase of the K10+K6- population. A correlation was found between the clinical response of calcipotriol and the K10+K6- population, and the clinical response of calcitriol and the K10+K6- population, as well as the percentage of cells in the S, G2 and M phase of the cell cycle within the K10-K6- population, suggesting that the analogues have a different preference for affecting the K10+K6- pool (committed differentiated cells) or affecting the K10-K6- pool (basal cells).

Adult↗
PubMed1993

Diflorasone diacetate ointment 0.05% versus betamethasone dipropionate ointment 0.05% in moderate-severe plaque-type psoriasis.

We report the results of a 2-week double-blind, parallel clinical trial comparing two superpotent topical glucocorticosteroid ointments, diflorasone diacetate 0.05% and betamethasone dipropionate 0.05%, in psoriatic adults. Both corticosteroid ointments were fast acting and highly efficacious. 40 of the 44 patients who initially enrolled completed the trial. There were no statistically significant differences between the two glucocorticoids with respect to erythema, scaling, induration or the investigator's global evaluation after either 1 or 2 weeks of therapy. The level of patient satisfaction with the efficacy and cosmetic acceptability of these two category I glucocorticoids was similar. No systemic or local adverse reactions were noted.

Administration, Topical↗
PubMed1983

Treatment of onychomycosis by ODT therapy with 20% urea ointment and 2% tolnaftate ointment.

20 patients with distal onychomycosis were given daily application of an ointment containing 2% tolnaftate and an ointment containing 20% urea under ODT. Following this, 17 of 20 patients developed onychomalacia and seven of these developed onycholysis 1 or 2 weeks later. The separated nails were cut as short as possible. Similarly to those patients with onychomalacia alone, occlusive dressing technique was continuously performed until the newly developed nails became macroscopically normal and no fungi were observed microscopically (responders). Following treatment, out of 20 patients, 14 responded. 5 patients who had a short course of treatment did not respond. Side-effects such as pain, hemorrhage and infection did not occur.

Administration, Oral↗