Study Details

Study Purpose

The purpose of this study is to see whether die-cut (sample cut of a whole patch) of Mylan’s formulation of Rotigotine transdermal system, 2 mg/24 hours manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc. (Mylan) will cause the same level of irritation (Example: redness) when compared to the die-cut of Neupro® Transdermal System, 2 mg/24 hours manufactured by UCB Inc. (UCB) after repeat application of the patch to the same test site.

Study Duration

The duration of your participation will include:

A screening visit (up to 28 days prior to Day 1 application)

Induction Phase: The induction phase consists of a 21-day Induction Phase. In this phase, you will receive two different study patches all containing 2.84 cm2 die-cut of one (1) 2 mg/24 hours Mylan Rotigotine Transdermal System and a 2.54 cm2 die-cut of one (1) 2 mg/24 hours Neupro® Transdermal System (UCB). Each study patch will be worn for 24 hours for 21 consecutive days to the same skin site of the abdomen. That means every day you will have a patch removed and a new patch applied to the same area of skin for 21 days.

A rest phase of 14 to 17 days during which there will be no application of the patches. Challenge Phase: The challenge phase is when each of the two study patches will be applied on a different area on your abdomen other than the induction phase and will be worn for 48 hours followed by 30 mins, 24, 48, and 72-hour skin assessments for irritation after patch removal. The challenge phase lasts a total of 5 days. An End of the Study Visit (within two weeks of last study related procedure i.e. last day of challenge phase examination).

If necessary, between 4 to 8 weeks after the completion of the challenge phase procedure, an additional 5days challenge (Re-challenge) phase, as determined by the study doctor

Study Schedule

General Screening

NA

Medical Screening

Contact recruitment

Study Visit(s)

Contact recruitment

Follow-Up Visit(s)

NA