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
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, see Learn About Clinical Studies.

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 August 28, 2014