Evaluation of the Efficacy, Tolerability, and Patient Acceptance of Dermatix Q for the Prevention and Management of Scars - Full Text View

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

This study is currently recruiting participants.
Verified by Innovative Medical, November 2007

Sponsored by:	Innovative Medical
Information provided by:	Innovative Medical
ClinicalTrials.gov Identifier:	NCT00450775

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 IV

MedlinePlus related topics:

Scars

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment

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

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
Estimated Study Completion Date:	March 2008

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

Contacts


Contact: melissa Earl	951-786-0403	m.earl@imedsonline.com

Contact: Jessica James	951-786-0403	jessie_imeds@sbcglobal.net

Locations


United States, Florida
	Dadeland Dermatology	Recruiting
	Coral Gables, Florida, United States, 33134
	Contact: David Rodriguez, MD 305-670-0260 darmd1@aol.com

Sponsors and Collaborators

Innovative Medical

Investigators


Principal Investigator:	David Rodriguez, MD	Dadeland Dermatology

More Information

Responsible Party:	Dadeland Dermatology ( David Rodriguez, MD )
Study ID Numbers:	5299
First Received:	March 20, 2007
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00450775
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases

Cicatrix

ClinicalTrials.gov processed this record on September 19, 2008