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Mederma to Reduce Appearance of Post Surgical Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01504061
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : October 24, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Scars Other: Mederma N&I Other: Mederma Ultra Gel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Official Title: The Comparison of Mederma® N&I to Mederma® Ultra Gel to Reduce the Appearance of Post Surgical Scars
Study Start Date : January 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

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.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01504061

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United States, North Carolina
Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Merz North America, Inc.
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Principal Investigator: Girish Munavalli, MD, MHS Dermatology, Laser, and Vein Specialists of Carolinas, PLLC
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Responsible Party: Merz North America, Inc. Identifier: NCT01504061    
Other Study ID Numbers: MUS90025-4007-0
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: October 24, 2013
Last Verified: October 2013
Keywords provided by Merz North America, Inc.:
Additional relevant MeSH terms:
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Pathologic Processes