NCT00651820

Brief Summary

A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment versus vehicle alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2008

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

First Submitted

Initial submission to the registry

March 20, 2008

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 26, 2011

Completed
Last Updated

June 9, 2011

Status Verified

June 1, 2011

Enrollment Period

1.6 years

First QC Date

March 20, 2008

Results QC Date

June 4, 2010

Last Update Submit

June 7, 2011

Conditions

ScarringImpaired Wound Healing

Keywords

wound healingscarringcollagenaseSantyl

Outcome Measures

Primary Outcomes (1)

  • Time to Complete Wound Closure Collagenase Santyl and Vehicle

    21 days

Secondary Outcomes (1)

  • Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle

    9 Months

Study Arms (2)

Collagenase Santyl Rate of Wound Closure

EXPERIMENTAL

Dermatome-induced skin wounds treated with drug active (collagenase).

Drug: Collagenase Santyl

Vehicle Rate of Wound Closure

PLACEBO COMPARATOR

Dermatome-induced skin wounds treated with Vehicle alone.

Drug: Collagenase Santyl Vehicle

Interventions

Collagenase SantylDRUG

Dermatome-induced skin wounds treated with drug active. Each subject serves as his own control receiving both treatments in parallel.

Collagenase Santyl Rate of Wound Closure
Collagenase Santyl VehicleDRUG

Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.

Vehicle Rate of Wound Closure

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provide written informed consent
  • Willing to attend all required study visits

You may not qualify if:

  • Known hypersensitivity to Clostridial collagenase
  • Anticoagulants (blood thinners, including aspirin) within two weeks
  • Congenital skin disorder which affects keratinocytes, elastin, or collagen
  • Any dermatologic disease which may be aggravated or provoked by the wounding procedure
  • Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding
  • At risk of keloid or hypertrophic scar formation
  • Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed
  • Any skin disorder which causes delayed healing
  • Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome
  • Taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Herbert B. Slade, M.D., FAAAI
Organization
Healthpoint, Ltd.
bert.slade@healthpoint.com
817-900-4000

Study Officials

  • Herbert B Slade, MD

    Healthpoint

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 20, 2008

First Posted

April 3, 2008

Study Start

April 1, 2008

Primary Completion

November 1, 2009

Study Completion

March 1, 2010

Last Updated

June 9, 2011

Results First Posted

January 26, 2011

Record last verified: 2011-06

Locations

US(1)