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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00450775
First Posted: March 22, 2007
Last Update Posted: September 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Innovative Medical
  Purpose
The purpose of this study is to evaluate the efficacy and patient acceptance of Dermatix Q for the prevention and treatment of scarring.

Condition Intervention Phase
Scars Drug: Dermatix Q Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Efficacy, Tolerability, and Patient Acceptance of Dermatix Q for the Prevention and Management of Scars

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • efficacy [ Time Frame: 1 yr ]

Secondary Outcome Measures:
  • patient acceptance [ Time Frame: 1 yr ]

Estimated Enrollment: 12
Study Start Date: March 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Dermatix Q
Dermatix Q applied twice daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450775


Locations
United States, Florida
Dadeland Dermatology
Coral Gables, Florida, United States, 33134
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: David Rodriguez, MD Dadeland Dermatology
  More Information

Responsible Party: David Rodriguez, MD, Dadeland Dermatology
ClinicalTrials.gov Identifier: NCT00450775     History of Changes
Other Study ID Numbers: 5299
First Submitted: March 20, 2007
First Posted: March 22, 2007
Last Update Posted: September 25, 2008
Last Verified: September 2008