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

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00450775
First received: March 20, 2007
Last updated: September 23, 2008
Last verified: September 2008
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient acceptance [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David Rodriguez, MD, Dadeland Dermatology
ClinicalTrials.gov Identifier: NCT00450775     History of Changes
Other Study ID Numbers: 5299
Study First Received: March 20, 2007
Last Updated: September 23, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014