Mederma to Reduce Appearance of Post Surgical Scars
This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of Mederma N&I to Mederma Ultra Gel on the appearance of post-surgical scars.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
|Official Title:||The Comparison of Mederma® N&I to Mederma® Ultra Gel to Reduce the Appearance of Post Surgical Scars|
- Investigator assessment of post-surgical scar appearance (indices are erythema, softness, texture, and overall appearance). This assessment is accompanied by photography and dermaspectrophotometry. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Experimental: Mederma Ultra Gel||
Other: Mederma Ultra Gel
Topical gel applied once daily for eight weeks.
|Active Comparator: Mederma N&I||
Other: Mederma N&I
Topical gel applied three times a day for eight weeks.
This is a 10-week research study designed to compare the effect of two gels on the appearance of post surgical scarring of the chest and/or back. The subject will be asked to identify two symmetrical skin growths that they would like to have removed: one on the left chest and/or back and one on the right chest and/or back. Additionally, the subject will identify a third skin growth that they would like removed which is a reasonable distance from the two symmetrical skin growths and will be located either on the back or the chest.
- Healthy male and non pregnant female subjects ≥18 years of age
- have seborrheic keratoses on the right and left chest and/or back
-Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
|United States, North Carolina|
|Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC|
|Charlotte, North Carolina, United States, 28207|
|Principal Investigator:||Girish Munavalli, MD, MHS||Dermatology, Laser, and Vein Specialists of Carolinas, PLLC|