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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.
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:
Exclusion Criteria:
-Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mederma Ultra Gel | Experimental |
| |
| Mederma N&I | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mederma N&I | Other | Topical gel applied three times a day for eight weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator assessment of post-surgical scar appearance (indices are erythema, softness, texture, and overall appearance). This assessment is accompanied by photography and dermaspectrophotometry. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Girish Munavalli, MD, MHS | Dermatology, Laser, and Vein Specialists of Carolinas, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC | Charlotte | North Carolina | 28207 | United States |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Mederma Ultra Gel |
| Other |
Topical gel applied once daily for eight weeks. |
|