Mederma to Reduce Appearance of Post Surgical Scars

Not Applicable

Completed

• Conditions: Scars
• Interventions: Other: Mederma N&I; Other: Mederma Ultra Gel

• Registration Number: NCT01504061
• Lead Sponsor: Merz North America, Inc.

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.

Study Timeline

• Study First Submitted: 2011-12-06
• Study Start: 2012-01
• Study First Submitted QC: 2012-01-02
• Study First Posted: 2012-01-05
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mederma N&I	Mederma N&I	-
Mederma Ultra Gel	Mederma Ultra Gel	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC; 🇺🇸 Charlotte, North Carolina, United States