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Combination of calcipotriene (Dovonex) ointment and tazarotene (Tazorac) gel versus clobetasol ointment in the treatment of plaque psoriasis: a pilot study.

BACKGROUND: Both calcipotriene and tazarotene have been shown to be effective in the treatment of psoriasis. No study has evaluated the effect of using both agents simultaneously. OBJECTIVE: Our purpose was to evaluate the effectiveness of combination treatment of psoriasis with calcipotriene ointment and tazarotene gel by comparing them with clobetasol ointment, a class I topical corticosteroid. A secondary objective was to evaluate the clinical compatibility of applying both agents at the same time. METHODS: This pilot study was a prospective, single-center, open-label, right/left comparison of 28 lesion pairs in 15 patients. It consisted of a 2-week treatment phase, followed by a 4-week post-treatment observation phase. RESULTS: All 15 patients completed the treatment phase of the study. At the end of the active treatment phase (end of week 2), calcipotriene- and tazarotene-treated lesions showed nearly identical reductions in scaling (P =.93), plaque elevation (P =.76), and overall lesional severity scores (P =.29) compared with their matched clobetasol-treated counterparts. Erythema improved significantly more in clobetasol-treated lesions (P <.05) during the treatment period, but differences became statistically insignificant during the post-treatment period (;P =.20). No patients had significant irritation from the treatments. During the post-treatment phase (weeks 3-6), all lesions worsened; plaque elevation returned somewhat more rapidly in calcipotriene- and tazarotene-treated lesions (P <.01), whereas changes in scaling, erythema, and overall lesional severity were not significantly different between the two treatment groups (P >.05). CONCLUSION: The nonsteroid combination of twice-daily calcipotriene ointment and once-daily tazarotene gel was not statistically different from twice-daily application of the class I corticosteroid clobetasol ointment in reducing psoriatic scaling, plaque elevation, and overall lesional severity over a 2-week period. There does not seem to be any chemical incompatibility between calcipotriene ointment and tazarotene gel that is clinically significant.

Administration, Cutaneous↗

Efficacy of once-daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris.

BACKGROUND: A two-compound ointment containing calcipotriol 50 micro g g-1 and betamethasone dipropionate 0.5 mg g-1 has recently been shown to be an effective treatment for psoriasis. OBJECTIVES: This study was designed to investigate efficacy and safety of different treatment regimens with the two-compound product (Daivobet/Dovobet; LEO Pharma, Ballerup, Denmark) and calcipotriol 50 micro g g-1 ointment (Daivonex/Dovonex; LEO Pharma). METHODS: In total, 972 patients with psoriasis vulgaris were randomized to one of three treatment regimens: group 1, the two-compound product once daily for 8 weeks followed by calcipotriol ointment once daily for 4 weeks; group 2, the two-compound product once daily for 4 weeks followed by 8 weeks of treatment with calcipotriol ointment once daily on weekdays and the two-compound product once daily at weekends; and group 3, calcipotriol ointment twice daily for 12 weeks. The efficacy was evaluated by Psoriasis Area and Severity Index (PASI) and investigators' global assessments of disease severity. The primary response criteria were percentage reduction in PASI and proportion of patients with absent/very mild disease according to the investigators' global assessments after 8 weeks of treatment. RESULTS: The mean reduction in PASI from baseline to the end of 8 weeks of treatment was 73.3% for group 1, 68.2% for group 2 and 64.1% for group 3. The proportion of patients with absent/very mild disease at the end of 8 weeks of treatment was 55.3% for group 1, 47.7% for group 2 and 40.7% for group 3. For both primary response criteria, group 1 was statistically superior to group 3 (P < 0.001), whereas group 2 did not differ significantly from group 3. The difference between group 1 and group 2 was statistically significant with regard to PASI but not regarding the proportion of patients with absent/very mild disease. Patients receiving initial therapy with the two-compound product achieved the fastest treatment response, and the maximum treatment effect for these patients was seen after 5 weeks. This effect was maintained with continued treatment with the two-compound product for up to 8 weeks. After 12 weeks of treatment, no significant differences were seen between the three groups with regard to reduction in PASI, whereas the proportion of patients with absent/very mild disease in group 2 was superior to that in group 3. Patients receiving therapy with the two-compound product experienced fewer lesional/perilesional adverse drug reactions than the calcipotriol-treated patients (P < 0.001): 10.9% in group 1, 11.5% in group 2 and 22.3% in group 3. CONCLUSIONS: Two different short-term treatment regimens employing a recently developed two-compound product (calcipotriol/betamethasone dipropionate) provided rapid and marked clinical efficacy and were shown to be safe therapies for psoriasis vulgaris.

Adolescent↗

[The role of ointment bases in the formulation of 2 antifungal drugs. II. Liberation studies on 5-fluorocytosine and tolnaftate ointment bases by the microbiological agar plate method].

In this study a microbiological in vitro agar plate method was developed to measure the liberation of two antifungal agents; 5-Fluorocytosine and Tolnaftate; comparatively from six different type ointment bases. The effect of dimethylformamide to the liberation of these two antifungals was also studied. Cetyl alcohol ointment and Emulsion ointment (B.P. 1968) bases gave the best results for the two active agents. Dimethylformamide accelerated the release of these antifungals from the emulsion type bases (Emulsion Ointment and Simple Ointment).

Chemistry, Pharmaceutical↗

[Clinical studies on zinc oxide ointment replacing boric acid and zinc oxide ointment (JP8)].

A boric acid and zinc oxide ointment (J.P. VIII) is an unique preparation in Japan, which consist of boric acid (5%), zinc oxide (10%), vegetable oil (usually soybean oil or sesame oil) and yellow wax. The ointment is widely used in the area of Hokkaido, because not only of the customary prescription but also of the characteristic clinical efficiency. However, boric acid has been recognized to be harmful in these days. Therefore, a zinc oxide ointment consisting 10% zinc oxide, soybean oil and white beeswax was tentatively made and evaluated. The zinc oxide ointment presented the same consistency as the boric acid and zinc oxide ointment, measured with penetrometer. The clinical efficiency was also confirmed on six patients with chronic eczema and seven patients with psoriasis vulgaris. The effect on wound healing of the donor site of skin graft was as good as the previous preparation.

Boric Acids↗

A comparison of fluticasone propionate ointment, 0.005%, and hydrocortisone-17-butyrate ointment, 0.1%, in the treatment of psoriasis.

The efficacy and safety of twice-daily topical application of fluticasone propionate ointment, 0.005%, and hydrocortisone-17-butyrate ointment, 0.1%, were compared in 113 adult patients with moderate-to-severe psoriasis in a multicenter, double-blind, randomized, parallel study. The majority of patients had psoriatic involvement of long duration over a large body surface area (mean, 17%). The following efficacy assessments were made at weekly intervals for up to four weeks following initiation of treatment: physician's gross assessment of clinical response of the target lesion; severity of psoriatic signs and symptoms; and patients' assessment of treatment effects. Safety was assessed by monitoring and reporting any adverse events that occurred during the study. Fluticasone propionate ointment, 0.005%, was found to be therapeutically superior to hydrocortisone-17-butyrate ointment, 0.1%, as well as safe and well tolerated. Its onset of action was rapid and no systemic adverse effects occurred. Overall patients experienced progressive improvement with fluticasone propionate ointment, 0.005%.

Administration, Topical↗

Topical antibiotic ointments for staphylococcal nasal carriers: survey of current practices and comparison of bacitracin and vancomycin ointments.

One measure used in the management of staphylococcal disease outbreaks in newborn nurseries is to obtain nasal cultures from nursery personnel and then treat nasal carriers with topical antibiotic ointments. Because recent infection control guide-surveyed current practices in larger hospitals in the U.S.A. Seventy-one percent of respondents indicated that they would obtain nasal cultures from personnel during a staphylococcal disease outbreak, and 40% indicated that they would prescribe topical antibiotic ointments for personnel with positive nasal cultures before the results of bacteriophage typing became known. Because little has been written about the efficacy of topical intranasal antibiotics within the past decade, we compared bacitracin ointment with a vancomycin ointment for treatment of the staphylococcal nasal carrier state. Both ointments reduced nasal carriage in the majority of instances. However, similar reduction was also observed in an untreated control group. The need for different approaches to the problem of nasal carriers is discussed.

Administration, Topical↗

[Extraction and determination of prednisolone in drugs and excipients in ointments and creams and the uniformity of distribution in prednisolone ointment].

For the purpose of measuring the contents of prednisolone in low concentrated ointments and creams an instruction was elaborated that includes several steps of extraction, in the resulting solution of which the assay of the steroid by Blue Tetrazolium reaction will be done. The procedure permits the determination of prednisolone in presence of most of usual ingredients of ointment bases except wool alcohols. Also no influence is given by some remedies combined with prednisolone for topical application except coal tar solution. The results confirm a correct reflection of the steroid contents declared respectively the recovery of the steroid added to various ointment bases. Introducing discussion to content uniformity concerning low concentrated ointments is made, and some deviations are shown.

Drug Compounding↗

Randomized, prospective trial comparing 0.25 percent glycerin trinitrate ointment and anal cryothermal dilators only with 0.25 percent glycerin trinitrate ointment and only with anal cryothermal dilators in the treatment of chronic anal fissure: a two-year follow-up.

PURPOSE: The objective of this study was to compare the efficacy of 0.25 percent glycerin trinitrate ointment in association with cryothermal anal dilators with 0.25 percent glycerin trinitrate ointment only and cryothermal anal dilators only. METHODS: A total of 48 patients suffering from chronic anal fissure were enrolled in this prospective, randomized study between January 2002 and December 2003: Group A, 16 patients were treated with 0.25 percent glycerin trinitrate ointment and also used cryothermal anal dilators; Group B, 16 patients were treated with 0.25 percent glycerin trinitrate ointment only; Group C, 16 patients were treated with cryothermal anal dilator use only. All patients in each group followed the specified treatment protocol for six weeks. RESULTS: After seven weeks of treatment, the symptoms complained of were resolved in 15 patients (93.7 percent) in Group A, 12 patients (75 percent) in Group B, and 12 patients (78 percent) in Group C. After two years of follow-up, 14 patients (87.5 percent) in Group A, 9 patients (56.2 percent) in Group B, and 10 patients (62.5 percent) in Group C presented no recurrence of symptoms. No patient in any group reported serious side effects of the treatment proposed, and treatment did not have to be withdrawn in any of the randomized patients. No episodes of anal incontinence of gas or feces were recorded in the patients who had used the anal dilators. CONCLUSIONS: The combined treatment for chronic anal fissure proved to be efficacious, safe, and with statistically significant better results than the other treatments analyzed.

Adolescent↗

Comparison of topical tacrolimus 0.1 % in pectin ointment with clobetasol 0.5% ointment in adults with moderate to severe desquamative gingivitis: A 4-week, randomized, double-blind clinical trial.

BACKGROUND: Desquamative gingivitis (DG) is a clinical condition characterized by red, painful, glazed, and friable gingiva, which might be a manifestation of some autoimmune mucocutaneous diseases. The time from the development of initial signs of DG to diagnosis can vary from months to years. Based on a literature search, no data concerning patients with DG without signs of autoimmune disease were available. OBJECTIVE: The aim of this trial was to compare the efficacy and tolerability of monotherapy with topical tacrolimus 0.1% in pectin ointment versus clobetasol propionate 0.5% ointment in adults affected by DG. METHODS: This randomized, double-blind clinical trial was conducted at the Dipartimento di Medicina Clinica e Sperimentale, Universita di Verona, Verona, Italy. Patients aged > or =18 years were selected using the department's electronic medical records based on a clinical diagnosis of moderate to severe DG. After a 2-week washout period, patients were randomly assigned to receive 2 mL of tacrolimus 0.1% in pectin (equivalent to 0.2 mg of tacrolimus) or 2 mL of clobetasol propionate 0.5% ointment (equivalent to 1 mg of clobetasol) QD for 4 weeks. Evaluations were performed before treatment (baseline), after the treatment period (week 4), and at 2 follow-up visits at weeks 6 and 8. The signs of DG (ie, erythema [atrophy] and desquamation [erosions/ulceration]) were quantified by a blinded investigator using a calculated score based on their surface extension, using a drawing in which the areas of various zones of the mouth were indicated as a percentage of the whole oral mucosa. Severity of erythema and desquamation was rated on a 4-point scale (0 = absent; 1 = involvement of <5% of surface [mild]; 2 = 5%-15% [moderate]; and 3 = >15% [severe]). The primary end point was the number of patients who achieved remission (severity score of 0) in either sign; the secondary end point was the proportions of patients achieving improvement (severity score of 0 or 1) in either sign. Before and after treatment, we measured the serum concentrations of tacrolimus and its metabolites with an immunoenzymatic assay kit. Tolerability was assessed using hematology, biochemistry, urinalysis, measurements of systolic/diastolic blood pressure and heart rate, patient interview, and spontaneous reporting. RESULTS: A total of 24 patients (18 women, 6 men; all white of Italian origin; age range, 21-65 years; 12 patients per treatment group) were enrolled in the study. In the tacrolimus group, 11 (91.7%) patients achieved remission of erythema and/or desquamation at weeks 4 and 6; at week 8, these rates were 9 (75.0%) and 8 (66.7%), respectively; none of the patients in the clobetasol group achieved remission of either sign at any time point (all, P < 0.001). At weeks 4, 6, and 8, significantly greater proportions of patients treated with tacrolimus had improved erythema and desquamation compared with those treated with clobetasol (all, P < 0.001). At week 4, all patients had undetectable serum tacrolimus concentrations (<1.5 microg/L). Six (50.0%) patients in the tacrolimus group reported a mild oral burning sensation, and 6 (50.0%) patients in the clobetasol group reported mild mouth dryness. No other adverse events were reported. CONCLUSIONS: The results of this small study suggest that topical tacrolimus 0.1 % in pectin was more effective compared with clobetasol propionate 0.5% ointment in the treatment of DG. Both treatments were generally well tolerated in the population studied.

Administration, Topical↗

Intra-individual comparison of the cutaneous safety and efficacy of calcitriol 3 microg g(-1) ointment and calcipotriol 50 microg g(-1) ointment on chronic plaque psoriasis localized in facial, hairline, retroauricular or flexural areas.

BACKGROUND: Psoriasis involving sensitive skin areas remains difficult to treat because of the side-effects of topical corticosteroids and the irritancy potential of vitamin D3 derivatives. Several clinical trials have demonstrated that calcitriol, the naturally occurring and hormonally active form of vitamin D3, is effective and safe at the dose of 3 microg g(-1) for the treatment of psoriasis affecting the trunk and limbs. METHODS: We compared the safety and efficacy of calcitriol 3 microg g(-1) ointment and calcipotriol 50 microg g(-1) ointment in a multicentre, randomized, investigator-blinded, left-right comparison in mild to moderate chronic plaque psoriasis affecting sensitive areas, defined as being the face, hairline, retroauricular and flexural areas. One pair of symmetrical and bilateral target lesions was selected from each area and assessed for perilesional erythema, oedema, and stinging/burning. Global assessment of local tolerability and global improvement were rated by the investigator, and the subjects were asked to evaluate the tolerability and efficacy of each product and to express their global preference. RESULTS: In the 75 subjects, calcitriol and calcipotriol both led to clearing of at least one target lesion in 21 (28%) of the subjects each. Perilesional erythema (P < 0.001), perilesional oedema (P < 0.02) and stinging/burning (P < 0.001) were all significantly less severe with calcitriol than with calcipotriol. The subjects' evaluation of local tolerability was significantly (P < 0.0001) in favour of calcitriol. Ten treatment-related dermatological events occurred in eight subjects, including one subject who experienced skin discomfort on both sides. All other events occurred only on the calcipotriol-treated side (irritant dermatitis, six subjects; contact dermatitis, one subject). Global assessment of improvement from baseline by the investigators was significantly greater for the calcitriol-treated lesions (P < 0.02). The subjects' global preference was significantly in favour of calcitriol (P < 0.02). CONCLUSIONS: In the present study, calcitriol ointment was found to be better tolerated and would appear to be more effective than calcipotriol ointment in the treatment of psoriasis in sensitive areas.

Adolescent↗

Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis.

BACKGROUND: Vehicle-controlled studies have demonstrated the efficacy and safety of tacrolimus ointment in the treatment of patients with atopic dermatitis (AD). OBJECTIVE: This study was undertaken to compare 0.03% and 0.1% tacrolimus ointment with 1% hydrocortisone acetate ointment in children 2 to 15 years of age with moderate-to-severe AD. METHODS: Treatment was twice daily to affected areas for 3 weeks in this multicenter, randomized, double-blind, parallel-group study. The primary endpoint was the modified eczema area and severity index (mEASI) mean area under the curve (mAUC) as a percentage of baseline. RESULTS: Five hundred sixty patients were randomized and received at least one application of ointment. Discontinuations included 21 of 189 patients from the 0.03% tacrolimus group, 13 of 186 patients from the 0.1% tacrolimus group, and 20 of 185 patients from the hydrocortisone acetate group. The median mEASI mAUC as a percentage of baseline showed 0.03% and 0.1% tacrolimus to be significantly more effective than 1% hydrocortisone acetate (P <.001) and 0.1% tacrolimus to be more effective than 0.03% tacrolimus (P =.006). The mEASI mAUC as a percentage of baseline was 44.8%, 39.8%, and 64.0% for patients who received 0.03% tacrolimus, 0.1% tacrolimus, and 1% hydrocortisone acetate, respectively. Transient skin burning was the only adverse event to show a higher incidence in the tacrolimus treatment groups than in the hydrocortisone acetate group (P <.05). Laboratory parameters showed no treatment differences and no marked changes over time. CONCLUSION: Tacrolimus, 0.03% and 0.1%, was significantly more effective than 1% hydrocortisone acetate and 0.1% tacrolimus was more effective than 0.03% tacrolimus in the treatment of moderate-to-severe AD in children. No safety concerns were identified.

Administration, Topical↗

Treatment of first episodes of acute anal fissure: prospective randomised study of lignocaine ointment versus hydrocortisone ointment or warm sitz baths plus bran.

One hundred and three patients with an acute first episode of posterior anal fissure were randomised to receive a three week trial of lignocaine ointment (n = 33) versus hydrocortisone ointment (n = 35) or warm sitz baths combined with an intake of unprocessed bran (n =35). Seven patients were withdrawn owing to failure to adhere to the trial protocol. After one and two weeks of treatment symptomatic relief was significantly better among patients treated with sitz baths and bran than among patients treated with lignocaine ointment or hydrocortisone ointment. After three weeks there was no difference in symptomatic relief among the three groups. Patients treated with lignocaine, however, had significantly fewer healed fissures (60%) than patients treated with hydrocortisone (82.4%) or warm sitz baths and bran (87%). In this study warm sitz baths plus an intake of unprocessed bran came out as the treatment of choice for an acute first episode of posterior anal fissure. This treatment is cheap, has no potential serious side effects, and brings the best and quickest relief of symptoms.

Acute Disease↗

[Ointment treatment of 1st degree hemorrhoids. Comparison of the effectiveness of a phytogenic preparation with two new ointments containing synthetic drugs].

OBJECTIVES: Investigation of the usefulness of a vegetable-based hemorrhoid ointment in comparison with two other ointments containing synthetic substances, one of which additionally contained corticoid. STUDY DESIGN: Treatment of 90 patients with first-degree hemorrhoids in the surgical department of a University Polyclinic, within the framework of a double-blind three-limb study of 21 days duration. Follow-up examinations on the third, seventh, fourteenth and twenty-first day of treatment. TARGET CRITERIA: Four typical symptoms--pruritus, bleeding, burning sensation, sore sensation--graded by both physician and patient. RESULTS: All three ointments proved highly effective. Both during the course of treatment and at the final examination carried out on the 21st day, no major differences were to be found between the three treatment groups. In the case of some of the test parameters, a positive tendency in favor of the herbal ointment was observed.

Adult↗

[Studies on phototoxic and photoallergic effects of cream, ointment and fatty ointment of fluocortin butylester (author's transl)].

The phototoxic action of ointment and fatty ointment of butyl 6alpha-fluoro-11beta-hydroxy-16alpha-methyl-3,20-dioxo-1,4-pregnadien-21-oate (fluocortin butylester, Vaspit) was examined by means of the epicutaneous test with subsequent UV-irradiation (Kromeyer lamp with Schott filter DG 18) in 20 patients with skin disorders. Photoallergic effects of fluocotrin butylester cream, ointment and fatty ointment were tested in a modified Draize test in which 198 subjects with normal skin participated. The subjects were sensitized in 10 epicutaneous tests conducted at intervals of 24 h and followed by irradiation (1500 W xenon lamp) with 2 MED. Treatment and irradiation were then repeated after a 2-week interval. This proceding permitted additional statements an phototoxicity of the administered preparations. No positive reactions occurred in either of the tests so that phototoxic effects can be excluded and a photoallergic potential is improbable.

Adolescent↗

Comparison of amcinonide ointment 0.1 percent twice daily and fluocinonide ointment 0.05 percent three times daily in the treatment of psoriasis.

Thirty-nine patients with psoriasis were treated either with amcinonide ointment 0.1 percent twice a day or with fluocinonide ointment 0.05 percent three times a day in a two-week, randomized, parallel-group, double-blind study. The severities of the skin lesions at baseline and at weekly intervals and the overall improvement at weekly intervals were evaluated by the investigator and the patient. The skin lesions improved significantly (p less than or equal to 0.01) over their condition at baseline, with good overall improvement attained by both treatment groups within one week. Both treatments were well tolerated. Amcinonide ointment 0.1 percent applied twice a day was found to be as effective and acceptable to patients as was fluocinonide ointment 0.05 percent applied three times a day in the treatment of psoriasis.

Double-Blind Method↗

[Therapeutic efficacy of lanoconazole ointment in guinea pig model of tinea corporis, a comparative study with ointment and cream preparations].

The therapeutic efficacy of ointment and cream preparations of lanoconazole in a guinea pig model of tinea corporis was compared on the basis of degrees of improvement in local symptoms and negative culture rates. When infected animals were treated once daily with 0.25%, 0.5% and 1% lanoconazole ointments, significant improvement of the symptoms and mycological curative effects were observed as compared to those of non-treated control and vehicle-treated control groups of animals. Particularly, in animals treated with 0.5 or 1% lanoconazole ointment, no fungus was recovered from any infected loci. Comparing these results with those obtained with comparable concentrations of lanoconazole cream, no significant difference was found. These studies, therefore, suggested that ointment and cream preparations of lanoconazole on topical application would show basically equivalent therapeutic efficacy in the tinea corporis model.

Animals↗

[Multicentre-clinical trial of the novel corticosteroid diflucortolone valerate in the forms of cream, ointment and fatty ointment. Part I: Comparative study of diflucortolone valerate with fluocortolone, -capronate, -pivalate in a double-blind contralateral design with topical application (author's transl)].

6alpha,9-Difluor-11beta-hydroxy-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione (diflucortolone valerate, Nerisona) 0.1% as a cream, ointment and fatty ointment was investigated in a double-blind contralateral design in 925 patients in comparison to fluocortolone (Ultralan), fluocortolone caproate and fluocortolone pivalate in three concurrently performed studies. The results of the contralateral study show Nerisona cream and ointment to be more effective (P less than 0.01) than Ultralan. The fatty ointment was also superior, but the difference was statistically significant (P less than 0.05) only in the indication psoriasis. No differences could be established in the less sensitive absolute assessment. The therapeutic success rate of 76-92% according to strict criteria-only complete healing and distinct improvement were counted as a success-clearly demonstrates the efficacy of the preparations. The local side effects recorded-mainly irritation and burning- were of a mild nature.

Administration, Topical↗

Comparison of fluticasone propionate ointment, 0.005%, and betamethasone-17,21-dipropionate ointment, 0.05%, in the treatment of psoriasis.

The efficacy, safety, and tolerability of the mid-potency corticosteroid, fluticasone propionate ointment, 0.005%, were compared with those of a high-potency corticosteroid, betamethasone-17,21-dipropionate ointment, 0.05%, in a twelve-week randomized, double-blind, parallel-group, multicenter study of seventy-four patients with moderate-to-severe psoriasis. Efficacy was evaluated for four weeks; safety was evaluated over a twelve-week period. Fluticasone ointment, 0.005%, was not significantly different from betamethasone ointment, 0.05%, at day 15 (P = 0.147), at the end of treatment analysis (P = 0.245), or at day 29 (P = 0.154). Neither medication resulted in any abnormal laboratory values over the twelve-week study period, including plasma cortisol levels. Both medications were well tolerated.

Administration, Topical↗