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Elastosis Senilis clinical trials

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NCT ID: NCT01583478 Recruiting - Skin Aging Clinical Trials

Comparison of Escalating Doses of IncobotulinumtoxinA (Xeomin®) in the Treatment of Glabellar Rhytids

Start date: September 2014
Phase: Phase 4
Study type: Interventional

The objective of the study is to compare the efficacy and duration of escalating doses of IncobotulinumtoxinA (Xeomin®) in the treatment of glabellar rhytids (frown lines between the eyes). Fifteen subjects will be enrolled in the study; specifically 60 male or female patients 18 years of age or older with moderate to severe glabellar rhytids at maximum contracture. Each patient will be randomized to receive one of 5 doses of Xeomin®, in a one-time dose to the treatment area. The efficacy endpoints will be determined by investigator and subject live assessment of the glabellar rhytids at rest and maximum contraction at each visit (every other day for 6 days post-injection, every month for 9 months following) using a validated 4 point photographic scale (minimal wrinkles [0], mild wrinkles [1], moderate wrinkles [2], or severe wrinkles [3]) used in previous studies. A written description of each photograph will be included to help standardize the application of the Photographic Scale.