Evaluation of the Efficacy, Tolerability, and Patient Acc... | NCT00450775

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

NCT00450775

Sponsor

Innovative Medical

Status

Completed

Last Update Posted

Sep 25, 2008Estimated

Enrollment

12Estimated

Phase

Phase 4

Conditions

Scars

Interventions

Dermatix Q

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Mar 20, 2007

First Submission Date that Met QC Criteria

Mar 21, 2007

First Posted Date

Mar 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2008

Last Update Posted Date

Sep 25, 2008Estimated

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Label	Type	Description	Intervention Names
1	Other		Drug: Dermatix Q

Name	Type	Description	Arm Group Labels	Other Names
Dermatix Q	Drug	Dermatix Q applied twice daily	1

Measure	Description	Time Frame
efficacy		1 yr

Measure	Description	Time Frame
patient acceptance		1 yr

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Rodriguez, MD	Dadeland Dermatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dadeland Dermatology		Coral Gables	Florida	33134	United States

Condition Browse Module

MeSH Terms

ID	Term
D002921	Cicatrix

Ancestor Terms

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided