Evaluation of the Efficacy, Tolerability, and Patient Acceptance of Dermatix Q for the Prevention and Management of Scars

September 23, 2008 updated by: Innovative Medical
The purpose of this study is to evaluate the efficacy and patient acceptance of Dermatix Q for the prevention and treatment of scarring.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Dadeland Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female or male patients at least 18 years of age
  • Patients who are at serious risk of hypertrophic scarring (due to family history, race, recent surgery, etc)
  • Able and willing to provide informed consent and likely to complete all study visits
  • All Fitzpatrick skin types will be evaluated

Exclusion Criteria:

  • Known contraindications to Dermatix or any of its components
  • Age of scar is > 4 months
  • Keloid scars (scars with increased fibroblastic activity that has exceeded the boundaries of the original scar)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1
Drug: Dermatix Q
Dermatix Q applied twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
efficacy
Time Frame: 1 yr
1 yr

Secondary Outcome Measures

Outcome Measure
Time Frame
patient acceptance
Time Frame: 1 yr
1 yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovative Medical

Investigators

  • Principal Investigator: David Rodriguez, MD, Dadeland Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 21, 2007

First Posted (ESTIMATE)

March 22, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 25, 2008

Last Update Submitted That Met QC Criteria

September 23, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • 5299

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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