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Effect of Collagenase on Healing and Scarring

Primary Purpose

Scarring, Impaired Wound Healing

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Collagenase Santyl

Collagenase Santyl Vehicle

About this trial

This is an interventional basic science trial for Scarring focused on measuring wound healing, scarring, collagenase, Santyl

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Provide written informed consent
Willing to attend all required study visits

Exclusion Criteria:

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

Sites / Locations

University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Collagenase Santyl Rate of Wound Closure

Vehicle Rate of Wound Closure

Arm Description

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

Dermatome-induced skin wounds treated with Vehicle alone.

Outcomes

Primary Outcome Measures

Time to Complete Wound Closure Collagenase Santyl and Vehicle

Secondary Outcome Measures

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

Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements.

Full Information

NCT ID

NCT00651820

First Posted

March 20, 2008

Last Updated

June 7, 2011

Sponsor

Healthpoint

1. Study Identification

Unique Protocol Identification Number

NCT00651820

Brief Title

Effect of Collagenase on Healing and Scarring

Official Title

A Randomized, Double-blind, Paired-Comparison of the Effect of Collagenase Santyl® Ointment on Healing and Scarring Characteristics of 600μm Dermatome Wounds

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Healthpoint

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scarring, Impaired Wound Healing

Keywords

wound healing, scarring, collagenase, Santyl

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Collagenase Santyl Rate of Wound Closure

Arm Type

Experimental

Arm Description

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

Arm Title

Vehicle Rate of Wound Closure

Arm Type

Placebo Comparator

Arm Description

Dermatome-induced skin wounds treated with Vehicle alone.

Intervention Type

Drug

Intervention Name(s)

Collagenase Santyl

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Collagenase Santyl Vehicle

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to Complete Wound Closure Collagenase Santyl and Vehicle

Time Frame

21 days

Secondary Outcome Measure Information:

Title

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

Description

Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements.

Time Frame

9 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provide written informed consent Willing to attend all required study visits Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Herbert B Slade, MD

Organizational Affiliation

Healthpoint

Official's Role

Study Director

Facility Information:

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

Country

United States

12. IPD Sharing Statement

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Effect of Collagenase on Healing and Scarring

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