Dermal Tolerability Comparison of a Marketed Transdermal System
Jeffrey E. Berg1, Chia-Ning Kao1, Micah Humphrey2, Marisa Flanagan3, Pauline Gearing4, Melissa L. Goodhead5.
1Hill Top Research, Miamiville, Ohio, USA; 2Hill Top Research, St. Petersburg, Florida, USA; 3Hill Top Research, Scottsdale, Arizona, USA; 4Former Employee Somerset Pharmaceuticals Inc., Tampa, Florida, USA, 5Somerset Pharmaceuticals Inc., Tampa, Florida.
This study was conducted as a Phase IV Post-Market Commitment to examine the adhesion and dermal tolerability of a once-daily transdermal patch in two populations consisting of non-elderly (18-64 years) and elderly (>65 years) healthy volunteers. This was an open-label, multicenter study of subjects randomized to one of three dose groups (6, 9 or 12 mg/24 hr). Each subject received a single patch, applied daily for 21 consecutive days. Subjects were randomized to receive the patches in one of three application areas (upper torso, including chest and back; upper arm or upper thigh). The transdermal systems consisted of rectangular patches that were 20cm2 (6mg/24hr dose), 30cm2 (9mg/24hr dose) or 40cm2 (12mg/24hr dose) in size. Skin irritation was assessed at 30 minutes and 24 hours after patch removal by trained evaluators and quantified using the scale of Berger and Bowman (0-7 point scale). Statistical comparisons of dermal irritation were made between the dosage groups (6, 9 or 12mg/24hr dose), age groups (18-64 yrs and >65 yrs) and study centers (St. Petersburg, FL and Scottsdale, AZ).
