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Aclovate (Alclometasone Dipropionate) - Summary



ACLOVATE® (alclometasone dipropionate cream) Cream, 0.05% and ACLOVATE® (alclometasone dipropionate ointment) Ointment, 0.05% contain alclometasone dipropionate (7α-chloro-11β,17,21 -trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17,21 -dipropionate), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

ACLOVATE® Cream and Ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ACLOVATE® Cream and Ointment may be used in pediatric patients 1 year 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). Since the safety and efficacy of ACLOVATE® Cream and Ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.

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Published Studies Related to Aclovate (Alclometasone)

[Alclometasone dipropionate (Legederm) for the treatment of steroid-sensitive dermatoses in the elderly] [1990.06]
This is a randomized single blind parallel comparison of alclometasone dipropionate cream 0.1% vs hydrocortisone butyrrate in 39 geriatric patients (greater than 60 years old) with steroid sensible skin diseases. The regimen consisted of dosing patients with two applications of the two drugs every day for 4 weeks.

Metabolic fate of alclometasone dipropionate in rats, rabbits, and mice. Metabolic products and pathway following subcutaneous administration. [1990.07]
The metabolic fate of alclometasone dipropionate (ADP or S-3460) has been studied in rats, rabbits, and mice, with consideration of their interspecies differences. Several reference compounds related to ADP were synthesized for the determination and identification of the metabolites.This M-1 was a main metabolite in plasma of animals studied, and due to its relatively longer life time in the media, it seemed to allow a variety of metabolism to occur, giving the oxidative and conjugative metabolites mentioned above.

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Clinical Trials Related to Aclovate (Alclometasone)

Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate Cream [Completed]
This is a multi-center, open-label study to evaluate whether participants follow the duration of use instructions for short-term use of alclometasone dipropionate in a population of participants with itchy skin conditions who would use OTC treatments for relief. The study population will be composed of two different cohorts: chronic condition sufferers (eczema or psoriasis) and participants who suffer from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.

Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO [Completed]
To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).

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Page last updated: 2006-01-31

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