Mederma to Reduce Appearance of Post Surgical Scars

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01504061
First received: December 6, 2011
Last updated: October 23, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504061

Locations
United States, North Carolina
Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
Investigators
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: October 23, 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 April 17, 2014