Mederma to Reduce Appearance of Post Surgical Scars

Scars Clinical Trial

Official title:

The Comparison of Mederma® N&I to Mederma® Ultra Gel to Reduce the Appearance of Post Surgical Scars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504061
• Other study ID #: MUS90025-4007-0
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: October 23, 2013
• Start date: January 2012
• Est. completion date: August 2012

Study information

• Verified date: October 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Scars

Intervention

Other:
• Mederma N&I
Topical gel applied three times a day for eight weeks.
• Mederma Ultra Gel
Topical gel applied once daily for eight weeks.

Locations

Country	Name	City	State
United States	Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes