Scars
Conditions
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
Topical gel applied three times a day for eight weeks.
Topical gel applied once daily for eight weeks.
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time 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