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

NCT ID: NCT00450775

Last Updated: 2008-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-03-31

Brief Summary

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

Detailed Description

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Conditions

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Scars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

Dermatix Q

Intervention Type DRUG

Dermatix Q applied twice daily

Interventions

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Dermatix Q

Dermatix Q applied twice daily

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Dadeland Dermatology

Principal Investigators

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David Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Dadeland Dermatology

Locations

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Dadeland Dermatology

Coral Gables, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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5299

Identifier Type: -

Identifier Source: org_study_id