NCT00531596

Evaluation of Adhesion and Dermal Tolerability of EMSAM

A PHASE IV, OPEN-LABEL STUDY OF THE ADHESION AND DERMAL TOLERABILITY OF EMSAM (SELEGILINE TRANSDERMAL SYSTEM) IN HEALTHY ADULT SUBJECTS OF TWO AGE GROUPS (18 - 64 YEARS, AND 65 YEARS AND OLDER)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Somerset Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Examine adhesive and dermal tolerability of EMSAm 6mg/24hr and 12mg/24hr in healthy elderly and non-elderly subjects.

Detailed description

The primary objectives of this study are to examine the adhesion characteristics and dermal tolerability (irritation) of EMSAM in two populations consisting of non-elderly (18 - 64 years) and elderly (65 years and older) healthy volunteers. EMSAM will be dosed over the range of proposed sizes for marketing \[(6mg/24hr), (9mg/24hr), and (12mg/24hr)\]. Adhesion and tolerability (irritation) will be examined at three different application site areas (upper torso \[includes chest and back\], upper arm, and upper thigh). The secondary objective is to examine if the adhesion characteristics and dermal tolerability (irritation) of EMSAM may be influenced by the secondary factors such as gender, race, physical activity, and bathing/showering practices.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	EMSAM (Selegiline Transdermal System) 6mg/24Hr	EMSAM 6mg/24HR
DRUG	EMSAM (Selegiline Transdermal System) 9mg/24Hr	EMSAM 9mg/24Hr
DRUG	EMSAM (Selegiline Transdermal System) 12mg/24hr	EMSAM 12mg/24Hr

Timeline

• Start date: 2007-04-01
• Completion: 2007-07-01
• First posted: 2007-09-19
• Last updated: 2007-09-19

Locations

2 sites across 1 country: United States