OLUX-E SUMMARY
Olux-E (clobetasol propionate) Foam, an emulsion aerosol foam, contains the active ingredient clobetasol propionate, USP, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.
Olux-E Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older (see PRECAUTIONS). Treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams per week (see DOSAGE AND ADMINISTRATION).
Patients should be instructed to use Olux-E Foam for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS).
Use in pediatric patients under 12 years of age is not recommended because of numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression seen in patients under 12 years of age (see PRECAUTIONS: Pediatric Use).
|
NEWS HIGHLIGHTS
Published Studies Related to Olux-E (Clobetasol Topical)
Effects of topical treatment with the raft modulator miltefosine and clobetasol in cutaneous mastocytosis: a randomized, double-blind, placebo-controlled trial. [2009.08.03]
Summary Background Mastocytosis is characterized by the accumulation and activation of mast cells in different organs, most commonly the skin. Miltefosine, a raft modulator, has recently been shown to inhibit the activation of mast cells and to reduce mast cell-driven skin inflammatory responses...
Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial. [2009.03]
BACKGROUND: Treatment of herpes simplex labialis (HSL) has been associated with modest benefits. This difficulty results from the rapid resolution of the disease accomplished by the immune system, which narrows the window of therapeutic opportunity. The immune response is also responsible for important clinical manifestations, including oedema and pain. The dual role of immune responses (protection, pathology) is well recognized in other infectious diseases. The addition of corticosteroids to antimicrobial agents has been associated with improvement in some of these diseases. OBJECTIVE: We evaluated the combination of oral valacyclovir plus topical clobetasol compared to placebo for recurrent HSL... CONCLUSIONS: This pilot study supports the addition of topical corticosteroids to an oral antiviral agent for the treatment of HSL. Larger studies need to confirm the safety and efficacy of this approach.
Topical clobetasol in the treatment of atrophic-erosive oral lichen planus: a randomized controlled trial to compare two preparations with different concentrations. [2009.02]
Oral lichen planus (OLP) is a chronic inflammatory disease that can be painful, mainly in the atrophic and erosive forms. Numerous drugs have been used with dissimilar results, but most treatments are empirical and do not have adequate control groups or correct study designs...
Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial. [2009.01.08]
Abstract Background Treatment of herpes simplex labialis (HSL) has been associated with modest benefits. This difficulty results from the rapid resolution of the disease accomplished by the immune system, which narrows the window of therapeutic opportunity...
Comparing clobetasol propionate 0.05% spray to calcipotriene 0.005% betamethasone dipropionate 0.064% ointment for the treatment of moderate to severe plaque psoriasis. [2009.01]
Topical corticosteroids are widely used in the treatment of psoriasis. This study was conducted to compare the efficacy and safety of clobetasol propionate (CP) 0.005% spray to calcipotriene 0.005%-betamethasome diproprionate 0.064% (C-BD) ointment in patients with moderate to severe plaque psoriasis...
Clinical Trials Related to Olux-E (Clobetasol Topical)
Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis [Not yet recruiting]
This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate)
Spray 0. 05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one
of two different regimens:
1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice daily on weekends (Sat - Sun) for 28 days
2. Clobex® Spray each morning and Vectical™ Ointment once each evening for 28 days
Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis [Recruiting]
Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus [Recruiting]
Lichen Sclerosus is an inflammatory skin condition affecting mostly the genital area of
persons of all ages, gender or race. The most frequent complaint is that of itchiness of the
vulva but pain may also occur. Some women will experience no symptoms at all. However, it is
important to treat this condition since it may increase and cause important scarring and
deformity. In less than 5% of cases, cancer may develop.
Lichen Sclerosus is a chronic disease which can be controlled but not cured. Topical
corticosteroids are the usual treatment for this condition. Though this treatment is
generally well tolerated, some patients may not present a sufficient response or may develop
mainly local and rarely systemic side effects. In this perspective, an alternative treatment
would be beneficial.
Tacrolimus, a topical immunomodulator has been approved for the treatment of atopic eczema
and has shown its efficacy in the treatment of vulvar lichen sclerosus in a limited number of
patients. Tacrolimus acts as a non-steroidal anti-inflammatory agent (NSAI) without causing
the usual side effects seen with the prolonged use of topical corticosteroids.
This study is designed to evaluate the safety and efficacy of tacrolimus in treating vulvar
lichen sclerosus by comparing it with the standard topical corticosteroid treatment.
Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp [Recruiting]
Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis [Not yet recruiting]
The Psoriasis and a chronic dermatosis characterized by abnormal proliferation of cells
epithelial, vessel dilation and inflammation locally, which presents erythematous-scaly
lesions in various areas of the body, preferably in the scalp, region and religious joints
as elbows and knees. It occurs equally in both sexes and can appear at any age, and the mean
age for the onset of the disease and around 27. 3 years.
The halobetasol propionate and an ultra-potent corticoid. Its chemical structure and similar
to the Clobetasol corticoid this, until then classified as the most potent corticoid used
worldwide in clinical practice. However, the molecular structure of Halobetasol gives it
increased its activity antiinflammatory and anti-proliferative.
The objective of this study is evaluating the efficacy and tolerability of the drug
Halobetasol propionate cream formulation as a treatment in patients with plaque psoriasis
mild to moderate, compared to the substance of similar power, Clobetasol propionate - Psorex - Cream.
|
