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Mederma to Reduce Appearance of Post Surgical Scars

NCT ID: NCT01504061

Last Updated: 2013-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Scars

Keywords

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surgical scars Mederma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Investigators

Study Groups

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Mederma Ultra Gel

Group Type EXPERIMENTAL

Mederma Ultra Gel

Intervention Type OTHER

Topical gel applied once daily for eight weeks.

Mederma N&I

Group Type ACTIVE_COMPARATOR

Mederma N&I

Intervention Type OTHER

Topical gel applied three times a day for eight weeks.

Interventions

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Mederma N&I

Topical gel applied three times a day for eight weeks.

Intervention Type OTHER

Mederma Ultra Gel

Topical gel applied once daily for eight weeks.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merz North America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Girish Munavalli, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Dermatology, Laser, and Vein Specialists of Carolinas, PLLC

Locations

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Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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MUS90025-4007-0

Identifier Type: -

Identifier Source: org_study_id