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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014