Mederma to Reduce Appearance of Post Surgical Scars

October 23, 2013 updated by: Merz North America, Inc.

The Comparison of Mederma® N&I to Mederma® Ultra Gel to Reduce the 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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz North America, Inc.

Investigators

  • Principal Investigator: Girish Munavalli, MD, MHS, Dermatology, Laser, and Vein Specialists of Carolinas, PLLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

January 2, 2012

First Posted (Estimate)

January 5, 2012

Study Record Updates

Last Update Posted (Estimate)

October 24, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUS90025-4007-0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Scars

Clinical Trials on Mederma Ultra Gel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe