NCT00450775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2008

Enrollment Period

1 year

First QC Date

March 20, 2007

Last Update Submit

September 23, 2008

Conditions

Scars

Outcome Measures

Primary Outcomes (1)

  • efficacy

    1 yr

Secondary Outcomes (1)

  • patient acceptance

    1 yr

Study Arms (1)

1

OTHER
Drug: Dermatix Q

Interventions

Dermatix QDRUG

Dermatix Q applied twice daily

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dadeland Dermatology

Coral Gables, Florida, 33134, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Rodriguez, MD

    Dadeland Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 22, 2007

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

US(1)