MOMETASONE SUMMARY
ELOCON® (mometasone furoate cream, USP) Cream 0.1% contains mometasone furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.
ELOCON Cream 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
ELOCON (mometasone furoate cream, USP) Cream 0.1% may be used in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS - Pediatric Use section). Since safety and efficacy of ELOCON Cream 0.1% have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended.
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NEWS HIGHLIGHTS
Published Studies Related to Mometasone (Mometasone Topical)
Effects of inhaled mometasone furoate on growth velocity and adrenal function: a placebo-controlled trial in children 4-9 years old with mild persistent asthma. [2011.10]
OBJECTIVE: To assess the effects of long-term mometasone furoate delivered via a dry powder inhaler (MF-DPI) on growth velocity and hypothalamic-pituitary-adrenal axis function in children with asthma... CONCLUSIONS: One year of treatment with a total daily dose of 100 mug of MF-DPI in the morning resulted in no significant difference, whereas a total daily dose of 200 mug of MF-DPI was associated with some changes in growth velocity when compared with placebo. The differences in growth velocity, and the absence of drug-related cortisol effects, support the use of a total daily dose of 100 mug of MF-DPI in children aged 4-9 years with mild persistent asthma.
Dysphagia and quality of life may improve with mometasone treatment in patients with eosinophilic esophagitis: a pilot study. [2011.10]
OBJECTIVE: The treatment of adult patients with eosinophilic esophagitis remains challenging. The aim was to assess dysphagia and health-related quality of life (HRQL) using validated scales and questionnaires before and after treatment with mometasone furoate... CONCLUSION: The dysphagia and impaired HRQL found in untreated patients with eosinophilic esophagitis improved significantly after 2 months of mometasone furoate treatment. A randomized placebo-controlled trial is warranted to assess causality. The scales and questionnaires used are sensitive instruments appropriate for symptom surveillance in individuals with eosinophilic esophagitis.
Application of mometasone spray to reduce sore throat after tracheal intubation. [2011.08]
CONCLUSION: Application of mometasone spray reduces postoperative sore throat after tracheal intubation.
The efficacy and tolerability of inhaled montelukast plus inhaled mometasone compared with mometasone alone in patients with chronic asthma. [2011.06]
BACKGROUND: The efficacy of oral montelukast in chronic asthma is well established. Montelukast is also an effective adjunctive therapy to inhaled corticosteroids (ICS) in asthma uncontrolled on ICS alone. Inhaled montelukast was recently shown to provide significant bronchodilation compared with placebo in patients with chronic asthma. The purpose of this study was to evaluate the efficacy of inhaled montelukast added to inhaled mometasone... CONCLUSION: Inhaled montelukast plus inhaled mometasone was significantly more effective than placebo plus inhaled mometasone in improving FEV(1), symptoms, asthma control, and blood eosinophil count.
Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: a phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4. [2011.04.01]
CONCLUSION: Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Clinical Trials Related to Mometasone (Mometasone Topical)
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED) [Completed]
This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy
of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice
daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind
treatment period, subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during
the run-in period. Efficacy will be measured by mean area under curve (AUC) of the change
from Baseline to Week 12 in FEV1.
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1) [Active, not recruiting]
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled,
parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate
(MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind
Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily (BID) for 2 to
3 weeks during the Run-in Period. Efficacy will be measured by mean change from Baseline to
Week 12 in area under the forced expiratory volume in one second concentration time curve
from 0 to 12 hours (FEV1 AUC[0-12 hr]).
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1) [Active, not recruiting]
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled,
parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate
(MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind
Treatment Period, subjects will receive open-label MF MDI 100 mcg twice daily (BID) for 2 to
3 weeks during the Run-in Period. Efficacy will be measured by mean change from Baseline to
Week 12 in area under the forced expiratory volume in one second concentration time curve
from 0 to 12 hours (FEV1 AUC[0-12 hr]).
Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between the Ages of 6 and Less Than 18 Years Old (Study P04292AM1) [Active, not recruiting]
The purpose of this study is to evaluate the safety and efficacy of Nasonex® (MFNS) in the
treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years
old. Safety will be the primary focus of this study.
Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers [Completed]
This study will compare the performance of three combination metered dose inhalation devices
and the variability of mometasone and formoterol doses delivered to the lungs in a healthy
volunteer population
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