Once-Daily MetroGel Deemed Advantageous for Rosacea : Skin & Allergy News
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`4/23/2013
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`Once-Daily MetroGel Deemed Advantageous for Rosacea : Skin & Allergy News
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`Page 2 of 3
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`Medical Dermatology
`
`Once-Daily MetroGel Deemed Advantageous for Rosacea
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`
`
`By: BRUCE JANCIN
`05/01/06
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`KOLOA, HAWAII — The metronidazole gel 1% approved by the Food
`and Drug Administration last year for the treatment of rosacea is a
`better product in two distinct ways than the 0.75% preparation it
`replaces, Dr. Guy F. Webster said at the annual Hawaii dermatology
`seminar sponsored by the Skin Disease Education Foundation.
`
`The new version incorporates a higher concentration of metronidazole,
`of course, but it also utilizes a new water-based, alcohol-free vehicle
`that's much gentler on the skin of atopic dermatitis patients (SKIN &
`ALLERGY NEWS, December 2005, p. 30).
`
`Indeed, patch test studies have shown that metronidazole gel 1%
`(MetroGel) has a very low potential for irritation. "It's clearly beneficial
`as a moisturizer, let alone as an anti-inflammatory drug," said Dr.
`Webster of Jefferson Medical College, Philadelphia.
`
`The pivotal phase III clinical trial that led to FDA approval last year
`involved 746 rosacea patients randomized 3:1 to 10 weeks of once-
`daily MetroGel or its gel vehicle.
`
`At 10 weeks, the mean inflammatory lesion count was reduced from a
`baseline of 18 by 51% in the MetroGel group and by 33% in controls.
`A total of 38% of patients in the MetroGel group was rated by
`investigators' global assessment as clear or almost clear and 29%
`were rated as unchanged, compared with 28% and 41%, respectively,
`of controls.
`
`In a separate phase IIIb clinical trial, MetroGel significantly
`outperformed azelaic acid gel 15% (Finacea) in terms of tolerability.
`
`The investigator-blinded multicenter study involved 180 rosacea
`patients randomized to 15 weeks of once-daily MetroGel or twice-daily
`Finacea.
`
`
`Specialty Focus
`
`The two treatments showed equal efficacy in terms of reductions in
`inflammatory lesions, erythema, and physicians' global severity
`scores; however, only 26% of patients in the MetroGel group indicated
`they were bothered by stinging and burning, compared with 47% on
`Finacea.
`
`Dr. Webster deemed that the cost of once-daily MetroGel was
`reasonable at slightly under $1 per day.
`
`A potential topical therapy for rosacea worth keeping an eye on is
`dapsone gel 5% (Aczone), he said. It received FDA marketing
`approval last year for acne vulgaris, but its manufacturer, QLT Inc.,
`has decided to delay the drug's launch until after completion of an
`ongoing phase IV study aimed at getting the FDA's requirement for
`patient blood tests removed. Meanwhile, a phase II study of Aczone
`for the treatment of rosacea is ongoing.
`
`Based on Aczone's pharmacokinetics, Dr. Webster said the FDA's
`restriction was likely to be lifted upon presentation of additional data
`by QLT.
`
`He is a consultant to Galderma, which markets MetroGel, but is not
`involved in the Aczone trials.
`
`The SDEF and this news organization are wholly owned subsidiaries of
`Elsevier.
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