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NCT00450775 Clinical Trial

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

Scars Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00450775
Other study ID # 5299
Secondary ID
Status Completed
Phase Phase 4
First received March 20, 2007
Last updated September 23, 2008
Start date March 2007
Est. completion date March 2008

Study information
Verified date September 2008
Source Innovative Medical
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and patient acceptance of Dermatix Q for the prevention and treatment of scarring.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Dermatix Q
Dermatix Q applied twice daily

Locations
Country Name City State
United States Dadeland Dermatology Coral Gables Florida

Sponsors (1)
Lead Sponsor Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary efficacy 1 yr No
Secondary patient acceptance 1 yr No
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