NCT01504061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2011

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 24, 2013

Status Verified

October 1, 2013

Enrollment Period

5 months

First QC Date

December 6, 2011

Last Update Submit

October 23, 2013

Conditions

Scars

Keywords

surgicalscarsMederma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Mederma Ultra Gel

EXPERIMENTAL
Other: Mederma Ultra Gel

Mederma N&I

ACTIVE COMPARATOR
Other: Mederma N&I

Interventions

Mederma N&IOTHER

Topical gel applied three times a day for eight weeks.

Mederma N&I
Mederma Ultra GelOTHER

Topical gel applied once daily for eight weeks.

Mederma Ultra Gel

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Girish Munavalli, MD, MHS

    Dermatology, Laser, and Vein Specialists of Carolinas, PLLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2011

First Posted

January 5, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

October 24, 2013

Record last verified: 2013-10

Locations

US(1)