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Double-blind, placebo-controlled, randomized study comparing 0.0003% calcitriol with 0.1% tacrolimus ointments for the treatment of endemic pityriasis alba.

ABSTRACT: Background. Pityriasis alba (PA) is a frequent cause of consultation in tropical areas due to its chronic course, frequent relapses, and notorious hypopigmented lesions in pediatric dark skin populations. Currently, no treatment is widely accepted. Objective. To assess the efficacy of 0.0003% calcitriol and 0.1% tacrolimus ointments compared with placebo in the treatment of endemic PA. Methods. Twenty-eight children aged 3-17 years with 56 symmetrical lesions and phototype IV-V, were randomly assigned to receive the treatments on target lesions on the face. Improvement was evaluated at baseline and 8 weeks later clinically and by digital quantification of the affected area, colorimetry, and transepidermal water loss (TEWL). Results. Tacrolimus and calcitriol ointments induced a mean improvement of 68%, compared to 44% of placebo. We found an elevated TEWL in PA lesions. In the treated plaques, the reduction of the affected area was associated with improvement of pigmentation and TEWL. Conclusions. Calcitriol and tacrolimus induced similar repigmentation in endemic PA lesions. Melanogenic, anti-inflammatory, and barrier defect restoration properties of these drugs may explain these findings.

SUBMITTER: Moreno-Cruz B

PROVIDER: S-EPMC3346967 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Double-blind, placebo-controlled, randomized study comparing 0.0003% calcitriol with 0.1% tacrolimus ointments for the treatment of endemic pityriasis alba.

Moreno-Cruz Berenice B Torres-Álvarez Bertha B Hernández-Blanco Diana D Castanedo-Cazares Juan Pablo JP

Dermatology research and practice 20120422

Background. Pityriasis alba (PA) is a frequent cause of consultation in tropical areas due to its chronic course, frequent relapses, and notorious hypopigmented lesions in pediatric dark skin populations. Currently, no treatment is widely accepted. Objective. To assess the efficacy of 0.0003% calcitriol and 0.1% tacrolimus ointments compared with placebo in the treatment of endemic PA. Methods. Twenty-eight children aged 3-17 years with 56 symmetrical lesions and phototype IV-V, were randomly as ...[more]

PMID: 22577371

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Project description:Hereditary hemorrhagic telangiectasia is a rare but ubiquitous genetic disease. Epistaxis is the most frequent and life-threatening manifestation and tacrolimus, an immunosuppressive agent, appears to be an interesting new treatment option because of its anti-angiogenic properties. Our objective was to evaluate, six weeks after the end of the treatment, the efficacy on the duration of nosebleeds of tacrolimus nasal ointment, administered for six weeks to patients with hereditary hemorrhagic telangiectasia complicated by nosebleeds, and we performed a prospective, multicenter, randomized, placebo-controlled, double-blinded, ratio 1:1 phase II study. Patients were recruited from three French Hereditary Hemorrhagic Telangiectasia (HHT) centers between May 2017 and August 2018, with a six-week follow-up, and we included people aged over 18 years, diagnosed with hereditary hemorrhagic telangiectasia and epistaxis (total duration > 30 min/6 weeks prior to inclusion). Tacrolimus ointment 0.1% was self-administered by the patients twice daily. About 0.1 g of product was to be administered in each nostril with a cotton swab. A total of 50 patients was randomized and treated. Mean epistaxis duration before and after treatment in the tacrolimus group were 324.64 and 249.14 min, respectively, and in the placebo group 224.69 and 188.14 min, respectively. Epistaxis duration improved in both groups, with no significant difference in our main objective comparing epistaxis before and after treatment (p = 0.77); however, there was a significant difference in evolution when comparing epistaxis before and during treatment (p = 0.04). Toxicity was low and no severe adverse events were reported. In conclusion, tacrolimus nasal ointment, administered for six weeks, did not improve epistaxis in HHT patients after the end of the treatment. However, the good tolerance, associated with a significant improvement in epistaxis duration during treatment, encouraged us to perform a phase 3 trial on a larger patient population with a main outcome of epistaxis duration during treatment and a longer treatment time.

Project description:IntroductionRecent studies show that antibiotic therapy is safe and feasible for CT-confirmed uncomplicated acute appendicitis. Spontaneous resolution of acute appendicitis has already been observed over a hundred years ago. In CT-confirmed uncomplicated acute diverticulitis (left-sided appendicitis), studies have shown no benefit from antibiotics compared with symptomatic treatment, but this shift from antibiotics to symptomatic treatment has not yet been widely implemented in clinical practice. Recently, symptomatic treatment of uncomplicated acute appendicitis has been demonstrated in a Korean open-label study. However, a double-blinded placebo-controlled study to illustrate the role of antibiotics and spontaneous resolution of uncomplicated acute appendicitis is still lacking.Methods and analysisThe APPAC III (APPendicitis ACuta III) trial is a multicentre, double-blind, placebo-controlled, superiority randomised study comparing antibiotic therapy with placebo in the treatment CT scan-confirmed uncomplicated acute appendicitis aiming to evaluate the role of antibiotics in the resolution of uncomplicated acute appendicitis. Adult patients (18-60 years) with CT scan-confirmed uncomplicated acute appendicitis (the absence of appendicolith, abscess, perforation and tumour) will be enrolled in five Finnish university hospitals.Primary endpoint is success of the randomised treatment, defined as resolution of acute appendicitis resulting in discharge from the hospital without surgical intervention within 10 days after initiating randomised treatment (treatment efficacy). Secondary endpoints include postintervention complications, recurrent symptoms after treatment up to 1 year, late recurrence of acute appendicitis after 1 year, duration of hospital stay, sick leave, treatment costs and quality of life. A decrease of 15 percentage points in success rate is considered clinically important difference. The superiority of antibiotic treatment compared with placebo will be analysed using Fisher's one-sided test and CI will be calculated for proportion difference.Ethics and disseminationThis protocol has been approved by the Ethics Committee of Turku University Hospital and the Finnish Medicines Agency (FIMEA). The findings will be disseminated in peer-reviewed academic journals.Trial registration numberNCT03234296; Pre-results.

Project description:BackgroundTo determine the efficacy of low-dose, immediate-release tacrolimus in patients with myasthenia gravis (MG) with inadequate response to glucocorticoid therapy in a randomized, double-blind, placebo-controlled study.MethodsEligible patients had inadequate response to glucocorticoids (GCs) after ⩾6 weeks of treatment with prednisone ⩾0.75 mg/kg/day or 60-100 mg/day. Patients were randomized to receive 3 mg tacrolimus or placebo daily (orally) for 24 weeks. Concomitant glucocorticoids and pyridostigmine were allowed. Patients continued GC therapy from weeks 1-4; from week 5, the dose was decreased at the discretion of the investigator. The primary efficacy outcome measure was a reduction, relative to baseline, in quantitative myasthenia gravis (QMG) score assessed using a generalized linear model; supportive analyses used alternative models.ResultsOf 138 patients screened, 83 [tacrolimus (n = 45); placebo (n = 38)] were enrolled and treated. The change in adjusted mean QMG score from baseline to week 24 was -4.9 for tacrolimus and -3.3 for placebo (least squares mean difference: -1.7, 95% confidence interval: -3.5, -0.1; p = 0.067). A post-hoc analysis demonstrated a statistically significant difference for QMG score reduction of ⩾4 points in the tacrolimus group (68.2%) versus the placebo group (44.7%; p = 0.044). Adverse event profiles were similar between treatment groups.ConclusionsTacrolimus 3 mg treatment for patients with MG and inadequate response to GCs did not demonstrate a statistically significant improvement in the primary endpoint versus placebo over 24 weeks; however, a post-hoc analysis demonstrated a statistically significant difference for QMG score reduction of ⩾4 points in the tacrolimus group versus the placebo group. This study was limited by the low number of patients, the absence of testing for acetylcholine receptor antibody and the absence of stratification by disease duration (which led to a disparity between the two groups). ClinicalTrials.gov identifier: NCT01325571.

Dataset Information

Double-blind, placebo-controlled, randomized study comparing 0.0003% calcitriol with 0.1% tacrolimus ointments for the treatment of endemic pityriasis alba.

Publications

Double-blind, placebo-controlled, randomized study comparing 0.0003% calcitriol with 0.1% tacrolimus ointments for the treatment of endemic pityriasis alba.

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