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Mederma to Reduce Appearance of Post Surgical Scars

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01504061
Enrollment
20
Registered
2012-01-05
Start date
2012-01-31
Completion date
2012-08-31
Last updated
2013-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scars

Keywords

surgical, scars, Mederma

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.

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.

Interventions

OTHERMederma N&I

Topical gel applied three times a day for eight weeks.

OTHERMederma Ultra Gel

Topical gel applied once daily for eight weeks.

Sponsors

Merz North America, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026