Mederma to Reduce Appearance of Post Surgical Scars
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Scars |
Other: Mederma N&I Other: Mederma Ultra Gel |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 20 |
| Study Start Date: | January 2012 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects must be 18-70 years of age, of any race or sex.
- Subjects must be Fitzpatrick skin type I-VI.
- Subjects must have two symmetrical upper chest and/or back seborrheic keratoses and in the opinion of the investigator are good candidates for the study.
Exclusion Criteria:
- Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
- Subjects with known history of keloids or hypertrophic scars.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Merz Pharmaceuticals, LLC |
| ClinicalTrials.gov Identifier: | NCT01504061 History of Changes |
| Other Study ID Numbers: | MUS90025-4007-0 |
| Study First Received: | December 6, 2011 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Merz Pharmaceuticals, LLC:
|
surgical scars Mederma |
Additional relevant MeSH terms:
|
Cicatrix Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013