Ignite Creation Date:
2025-12-17 @ 1:45 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT01504061
Status:
COMPLETED
Last Update Posted:
2013-10-24
First Post:
2011-12-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mederma to Reduce Appearance of Post Surgical Scars
Sponsor:
Merz North America, Inc.
Organization:
Study Overview
Official Title:
The Comparison of Mederma® N&I to Mederma® Ultra Gel to Reduce the Appearance of Post Surgical Scars
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Inclusion Criteria:
* Healthy male and non pregnant female subjects ≥18 years of age
* have seborrheic keratoses on the right and left chest and/or back
Exclusion Criteria:
-Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
Inclusion Criteria:
* Healthy male and non pregnant female subjects ≥18 years of age
* have seborrheic keratoses on the right and left chest and/or back
Exclusion Criteria:
-Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: