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Topical Ointment

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3841. Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle. (Abstract)

Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle. Intermittent dosing of a topical calcineurin inhibitor for preventing atopic dermatitis (AD) disease relapse in patients with stabilized AD has not been evaluated.We sought to evaluate the long-term efficacy and safety of 3-times-weekly use of tacrolimus ointment in preventing AD disease (...) relapse.Adult and pediatric patients with moderate to severe AD who were clear of disease after up to 16 weeks of treatment with tacrolimus ointment were randomized in a double-blind fashion to 3-times-weekly treatment with either tacrolimus ointment (0.03% or 0.1%) or vehicle for 40 weeks. The primary end point was the number of flare-free treatment days.A total of 125 patients were randomized to tacrolimus and 72 patients to vehicle. The mean number of flare-free treatment days was 177 for tacrolimus

2008 Journal of the American Academy of Dermatology Controlled trial quality: uncertain

3842. Tacrolimus ointment is effective for facial and intertriginous psoriasis. (Abstract)

Tacrolimus ointment is effective for facial and intertriginous psoriasis. Intertriginous and facial involvement are manifestations of psoriasis that require a different approach than is used for typical plaque psoriasis on other skin areas. Topical corticosteroids are the primary treatment for psoriasis; however, the side effects of corticosteroids are magnified on intertriginous and facial skin. Topical tacrolimus offers the potential for anti-inflammatory effect without the atrophy or other (...) local side effects associated with the use of topical corticosteroids.To determine the efficacy and tolerability of 0.1% tacrolimus ointment for the treatment of facial or intertriginous psoriasis.One hundred sixty-seven patients 16 years or older were evaluated in an 8-week, randomized, double-blind, vehicle-controlled, multi-center study. Upon entry into the study, patients were randomized 2:1 to apply the tacrolimus ointment 0.1% or vehicle twice daily to all psoriatic lesions of the face

2004 Journal of the American Academy of Dermatology Controlled trial quality: uncertain

3843. [A prospective, randomized double-blind study on the treatment of anal fissures with Nitroglycerin ointment]. (Abstract)

[A prospective, randomized double-blind study on the treatment of anal fissures with Nitroglycerin ointment]. Anal fissure is a common disease. Treatment includes conservative measures or surgery. One of the treatment options is topical Nitroglycerin ointment.We present a prospective, randomized, double-blind study, encompassing 48 patients suffering from chronic anal fissure. The subjects were divided into three groups according to the dose of Nitroglycerin ointment received--group I--0 (...) % (placebo), group II--0.2% (0.75 mg) and group III--0.4% (1.5 mg). Demographic data, medical history and physical findings were recorded. Healing, pain relief and adverse events were evaluated during and after the treatment period.No significant difference (p<0.05) was found between the groups with respect to patient age, gender, past history, physical examination, amount of ointment used and adverse events. Thirty three of the 48 (69%) patients completed the study. No significant differences were found

2004 Harefuah Controlled trial quality: uncertain

3844. Comparing tacrolimus ointment and oral cyclosporine in adult patients affected by atopic dermatitis: a randomized study. Full Text available with Trip Pro

Comparing tacrolimus ointment and oral cyclosporine in adult patients affected by atopic dermatitis: a randomized study. Atopic dermatitis (AD) is a chronic allergic inflammatory disease, which manifests itself with eczematous skin lesions.We compared the clinical efficacy of tacrolimus ointment (0.1%) given twice a day and oral cyclosporine (3 mg/kg) given once daily. Rescue medication for itching included cetirizine 10-20 mg (equal to one or two tables).Thirty patients, aged 13-45 years (mean (...) before the treatment (0) and at 7, 14, 21, 28, 35 and 42 days after treatment; finally, on day without use of cetirizine tablets. The safety of the study treatments was assessed through haematologic, biochemical and urinary testing and on systolic and diastolic blood pressures and heart rate measurements.SCORAD decreased in the two treatment groups 14 days after the beginning of the period study. However, the patients in tacrolimus ointment group reported significantly lower SCORAD than those treated

2004 Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology Controlled trial quality: uncertain

3845. 0.03% Tacrolimus ointment applied once or twice daily is more efficacious than 1% hydrocortisone acetate in children with moderate to severe atopic dermatitis: results of a randomized double-blind controlled trial. (Abstract)

0.03% Tacrolimus ointment applied once or twice daily is more efficacious than 1% hydrocortisone acetate in children with moderate to severe atopic dermatitis: results of a randomized double-blind controlled trial. Topical corticosteroids are the usual treatment for atopic dermatitis (AD) in children but can have side-effects.This study compared the efficacy and safety of 0.03% tacrolimus ointment applied once or twice daily over a 3-week period with the twice daily application of 1 (...) % hydrocortisone acetate (HA) ointment in children with moderate to severe AD.Patients applied ointment daily to all affected body surface areas. The primary study endpoint was the percentage change in the modified Eczema Area and Severity Index (mEASI) between baseline and treatment end.Six hundred and twenty-four patients, aged 2-15 years, applied 0.03% tacrolimus ointment once daily (n = 207), twice daily (n = 210) or 1% HA twice daily (n = 207). By the end of treatment, application of 0.03% tacrolimus

2004 The British journal of dermatology Controlled trial quality: predicted high

3846. Efficacy of paromomycin ointment in the treatment of cutaneous leishmaniasis: results of a double-blind, randomized trial in Isfahan, Iran. (Abstract)

Efficacy of paromomycin ointment in the treatment of cutaneous leishmaniasis: results of a double-blind, randomized trial in Isfahan, Iran. Although pentavalent antimonials are often used in the first-line treatment of cutaneous leishmaniasis (CL), they have several adverse effects. Intralesional administration of antimonials and other antileishmanial drugs can be painful. In the present, double-blind, randomized study, to determine if topical treatment with paromomycin is effective (...) healing, with the apparent clearance of amastigotes from their lesions, 30 and 60 days after treatment began, respectively. At the same time-points, however, the lesions on six (17%) and seven (20%) of the cases in the placebo group, respectively, also appeared to have healed completely. Ointment containing 15% paromomycin therefore appears ineffective in the treatment of CL, at least when applied twice daily for 30 days to the lesions of cases from an endemic area of Isfahan, Iran.

2005 Annals of Tropical Medicine and Parasitology Controlled trial quality: uncertain

3847. Comparative study of calcipotriol (0.005%) ointment and tazarotene (0.05% and 0.1%) gel in the treatment of stable plaque psoriasis. (Abstract)

Comparative study of calcipotriol (0.005%) ointment and tazarotene (0.05% and 0.1%) gel in the treatment of stable plaque psoriasis. Topical therapies are the first line of treatment for patients with stable plaque psoriasis affecting a limited body surface area. Though in use for more than a decade, we could not find any reports of studies directly comparing calcipotriol and tazarotene.To evaluate the comparative efficacy and tolerability of calcipotriol and tazarotene in the treatment (...) of stable plaque psoriasis.This was a prospective, right-left side intra-individual parallel 8-week study using calcipotriol 0.005% ointment applied twice daily (right side) versus tazarotene (left side) randomized to either 0.05% (group I) or 0.1% gel (group II) once daily in two groups, each of 10 patients. Efficacy was determined by the assessment of target psoriatic lesions under evaluation by using the severity scale (0-3) of erythema, scaling, and infiltration (ESI score). Evaluation was done

2008 Indian journal of dermatology, venereology and leprology

3848. The safety of tacrolimus ointment for the treatment of atopic dermatitis: a review. (Abstract)

The safety of tacrolimus ointment for the treatment of atopic dermatitis: a review. Tacrolimus ointment is a topical calcineurin inhibitor (TCI) that was developed specifically for the treatment of atopic dermatitis (AD). It is one of the most extensively tested dermatological products, with more than 19 000 patients (including approximately 7600 children) having participated in the tacrolimus ointment clinical development programme. Recent regulatory reviews have focused on the potential risk (...) of malignancy with TCIs, based on their mode of action and the effects of systemic tacrolimus when given to transplant recipients. Studies have shown, however, that the systemic absorption of tacrolimus when applied topically is very low, with blood concentrations being below the level of quantification in most patients. Moreover, TCIs are not associated with a decrease in immunocompetence in the skin and there is no increase in the incidence of infections with long-term treatment. More than 5.4 million

2007 British Journal of Dermatology

3849. Randomized clinical trial comparing botulinum toxin injections with 0.2 per cent nitroglycerin ointment for chronic anal fissure. (Abstract)

Randomized clinical trial comparing botulinum toxin injections with 0.2 per cent nitroglycerin ointment for chronic anal fissure. In recent years treatment of chronic anal fissure has shifted from surgical to medical. This study compared the ability of two non-surgical treatments-botulinum toxin injections and nitroglycerin ointment-to induce healing in patients with idiopathic anal fissure.One hundred adults were assigned randomly to receive treatment with either type A botulinum toxin (30 (...) units Botox or 90 units Dysport) injected into the internal anal sphincter or 0.2 per cent nitroglycerin ointment applied three times daily for 8 weeks.After 2 months, the fissures were healed in 46 (92 per cent) of 50 patients in the botulinum toxin group and in 35 (70 per cent) of 50 in the nitroglycerin group (P=0.009). Three patients in the botulinum toxin group and 17 in the nitroglycerin group reported adverse effects (P<0.001). Those treated with botulinum toxin had mild incontinence

2007 British Journal of Surgery Controlled trial quality: uncertain

3850. Vasodilative effect of isosorbide dinitrate ointment in complex regional pain syndrome type 1. Full Text available with Trip Pro

Vasodilative effect of isosorbide dinitrate ointment in complex regional pain syndrome type 1. In complex regional pain syndrome type 1 (CRPS1) vascular changes occur from the initial, inflammatory event onto the trophic signs during chronicity of the disease, resulting in blood flow disturbances and marked temperature changes. Pharmacotherapeutic treatment is generally inadequate.To determine whether local application of the nitric oxide donor isosorbide dinitrate (ISDN) could cause (...) vasodilation and thereby improve tissue blood distribution in the affected extremity.In a pilot study, 5 female patients with CRPS1 in one hand were treated with ISDN ointment 4 times daily during 10 weeks. As a primary objective videothermography was used to monitor changes in blood distribution in both the involved and contralateral extremities.Patients treated with ISDN showed an increase of 4 degrees C to 6 degrees C in mean skin temperature of the cold CRPS1 hands, reaching values similar

2008 Clinical Journal of Pain

3851. Tacrolimus 0.1% Ointment: Is It Really Effective in Plasma Cell Vulvitis?. Report of Four Cases. (Abstract)

Tacrolimus 0.1% Ointment: Is It Really Effective in Plasma Cell Vulvitis?. Report of Four Cases. Plasma cell vulvitis is a clinically and histologically well-characterized chronic disease that usually relapses after various topical therapies. Considering the inflammatory nature of the disease, the new topical calcineurin inhibitors have been also employed successfully in few cases of Zoon's balanitis, the corresponding male condition.The aim of our study is to evaluate the effectiveness (...) of tacrolimus ointment in a small group of plasma cell vulvitis sufferers.4 women affected by biopsy-proved plasma cell vulvitis were enrolled, after informed consent. The topical drug was applied twice daily for 6 weeks, then tapered on the basis of the clinical results. Symptoms and objective parameters were obtained periodically at the beginning, after 6 weeks and up to the end of the topical treatment. A final biopsy was performed in 3 out of our 4 patients. The follow-up is still ongoing.The

2008 Dermatology

3852. Pharmacokinetics of 0.1% tacrolimus ointment after first and repeated application to adults with moderate to severe atopic dermatitis. Full Text available with Trip Pro

). Peak concentrations after first ointment application were ointment applications. Both the rate and extent of topical absorption decreased as the skin lesions healed. (...) Pharmacokinetics of 0.1% tacrolimus ointment after first and repeated application to adults with moderate to severe atopic dermatitis. The systemic exposure to tacrolimus after first and repeated application of 0.1% tacrolimus ointment was investigated in 32 adults with moderate to severe atopic dermatitis. Patients were allocated to treatment groups according to the size of the affected area to be treated: Group 13000 cm(2)6000 cm(2

2005 Journal of Investigative Dermatology

3853. Detection of IgE antibodies to bacitracin using a commercially available streptavidin-linked solid phase in a patient with anaphylaxis to triple antibiotic ointment. (Abstract)

Detection of IgE antibodies to bacitracin using a commercially available streptavidin-linked solid phase in a patient with anaphylaxis to triple antibiotic ointment. Bacitracin is a commonly used topical antibiotic that has on occasion been reported to cause anaphylaxis. Evidence of the role of bacitracin specific IgE in such reactions has been demonstrated by skin testing. Because of the potential for provoking a systemic reaction by skin testing, it would be advantageous to develop (...) an in vitro test for bacitracin specific IgE.To report our experience coupling bacitracin to a solid phase and using it to detect specific IgE to bacitracin by fluorescent enzyme immunoassay.A patient with a history of recurrent anaphylaxis that developed after application of triple antibiotic ointment to an open wound underwent skin testing with triple antibiotic ointment. Bacitracin was biotinylated and coupled to streptavidin ImmunoCAPs. IgE against bacitracin in the patient's serum was detected

2007 Asthma & Immunology

3854. Therapeutic Effects of Tacrolimus Ointment for Refractory Ocular Surface Inflammatory Diseases. (Abstract)

Therapeutic Effects of Tacrolimus Ointment for Refractory Ocular Surface Inflammatory Diseases. To investigate the therapeutic effects of topical tacrolimus ointment on refractory ocular surface inflammatory diseases.Retrospective interventional consecutive case series.Ten consecutive patients with severe ocular surface inflammatory diseases who were suspected to be steroid responders (elevation of intraocular pressure [IOP]) or were refractory to standard steroid therapy were studied. One (...) patient had peripheral ulcerative keratitis with impending corneal perforation, 1 had a Mooren's ulcer, 2 had scleroperikeratitis, 5 had atopic keratoconjunctivitis, and 1 had vernal keratoconjunctivitis.The clinical findings and therapeutic responses after treatment with 0.02% topical tacrolimus ointment were determined by conventional ophthalmological examinations.Resolution of the ocular surface diseases (e.g., decrease of hyperemia, ulceration, size of papillae) and IOP. The necessity to use

2007 Ophthalmology

3855. Gentamicin ointment versus petrolatum for management of auricular wounds. (Abstract)

Gentamicin ointment versus petrolatum for management of auricular wounds. Surgeons frequently create defects on the ear in the treatment of cutaneous malignancies. Potentially significant complications of second-intention healing on the ear are suppurative and inflammatory chondritis. Consequently, many physicians advocate the use of oral or topical prophylactic antibiotics after auricular surgery.The purpose of this study is to compare the efficacy of gentamicin ointment (...) with that of petrolatum for the prevention of suppurative chondritis during second-intention healing of auricular wounds after Mohs surgery.One hundred forty-two patients with a total of 147 second-intention wounds were prospectively selected to receive either gentamicin ointment or petrolatum postoperatively.One hundred forty-four wounds were evaluated in a follow-up examination or by telephone interview. Eight (5.56%) wounds developed suppurative chondritis. Four wounds received gentamicin and four received

2005 Dermatologic Surgery

3856. Tacrolimus ointment promotes repigmentation of vitiligo in children: a review of 57 cases. (Abstract)

Tacrolimus ointment promotes repigmentation of vitiligo in children: a review of 57 cases. Vitiligo is an autoimmune disorder characterized by loss of pigmentation. Phototherapy and application of topical corticosteroids are most commonly prescribed. However, these therapies are often not effective and use of corticosteroids on the face may lead to cutaneous atrophy, telangiectasia, and ocular complications.We sought to assess the efficacy of topical tacrolimus ointment in the treatment (...) of pediatric vitiligo.A retrospective review was performed of 57 pediatric patients with vitiligo at two clinical sites. Patients were treated with tacrolimus ointment for at least 3 months. Clinical responses were documented during clinic visits, and by pretacrolimus and posttacrolimus photography.At least partial response was noted to tacrolimus ointment on the head and neck in 89%, and on the trunk and extremities in 63% of patients. Facial vitiligo of the segmental type showed the best response rate

2004 Journal of American Academy of Dermatology

3857. Treatment of eosinophilic pustular folliculitis with tacrolimus ointment. (Abstract)

Treatment of eosinophilic pustular folliculitis with tacrolimus ointment. We describe a patient with eosinophilic pustular folliculitis who partially responded to oral indomethacin, but intermittently experienced new eosinophilic pustular folliculitis lesions. Treatment with tacrolimus ointment 0.1% resulted in the rapid improvement of each recurred lesion and allowed withdrawal of indomethacin. To our knowledge, this is the first report of the use of topical tacrolimus in the treatment

2004 Journal of American Academy of Dermatology

3858. The efficacy and safety of tacrolimus ointment: a clinical review. (Abstract)

The efficacy and safety of tacrolimus ointment: a clinical review. Topical tacrolimus ointment was approved for the treatment of atopic dermatitis in Japan in 1999, the United States in 2000, and Europe in 2001. The safety and efficacy of tacrolimus ointment was established in vehicle-controlled, randomized, 12-week clinical trials; 1-year open-label trials; and comparative studies with topical steroids. Although an extensive database exists on the safety and efficacy of tacrolimus ointment (...) based on the global development program, clinicians desire additional information on the long-term safety and efficacy of this novel agent. In this supplement, additional studies are reported that extend the safety and efficacy profile of tacrolimus ointment in patients with atopic dermatitis, including long-term safety studies for up to 4 years. The studies presented in this supplement address important questions regarding the selection and use of tacrolimus ointment in the treatment of patients

2005 Journal of American Academy of Dermatology

3859. Pneumococcal seroconversion after vaccination for children with atopic dermatitis treated with tacrolimus ointment. (Abstract)

Pneumococcal seroconversion after vaccination for children with atopic dermatitis treated with tacrolimus ointment. We sought to determine the effect of treatment with topical tacrolimus on B- and T-cell immunity including the primary antibody response to pneumococcal polysaccharide vaccine in children with atopic dermatitis.In this open-label, noncomparative study, 23 children aged 2 to 12 years with moderate to severe atopic dermatitis were treated with tacrolimus 0.03% ointment twice daily (...) , immunoglobulin levels, antibody titers to tetanus and Haemophilus influenzae , or lymphoproliferative responses were noted during the tacrolimus ointment treatment period. Tacrolimus blood levels were 1 ng/mL or less in all 23 children. Protective pneumococcal titers to all 12 serotypes were observed in 2 of 23 (9%) children prevaccination and in 16 of 23 (70%) children postvaccination. All 6 children who had protective titers to 0 to 5 of the 12 serotypes developed protective titers to an additional 5 to 11

2005 Journal of American Academy of Dermatology

3860. Quality of life in patients with atopic dermatitis: impact of tacrolimus ointment. (Abstract)

Quality of life in patients with atopic dermatitis: impact of tacrolimus ointment. Atopic dermatitis (AD), a significant problem in Japan, has a major impact on health-related quality of life (QOL). The development of steroid phobia in patients with AD may restrict the therapeutic options available to these patients. Tacrolimus ointment is a safe and effective nonsteroid treatment for AD. It may be an appropriate alternative for patients with AD and steroid phobia. The aim of this study (...) was to determine the impact of AD on QOL and to investigate the effect of tacrolimus ointment on QOL in patients with steroid phobia.Firstly, QOL scores were investigated in patients with AD and steroid phobia using the World Health Organization Quality of Life instrument, WHOQOL-26, and were compared with QOL scores from a previous study in volunteers from Tokyo, Japan. Secondly, patients with steroid phobia received tacrolimus ointment treatment for 12 weeks. Quality of life scores were assessed using WHOQOL

2006 International Journal of Dermatology

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