Effect of Collagenase on Healing and Scarring

Scarring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651820
• Other study ID #: 017 101 09 001
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2008
• Last updated: June 7, 2011
• Start date: April 2008
• Est. completion date: March 2010

Study information

• Verified date: June 2011
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Provide written informed consent

2. Willing to attend all required study visits

Exclusion Criteria:

1. Known hypersensitivity to Clostridial collagenase

2. Anticoagulants (blood thinners, including aspirin) within two weeks

3. Congenital skin disorder which affects keratinocytes, elastin, or collagen

4. Any dermatologic disease which may be aggravated or provoked by the wounding procedure

5. Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding

6. At risk of keloid or hypertrophic scar formation

7. Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed

8. Any skin disorder which causes delayed healing

9. Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome

10. 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cicatrix
• Impaired Wound Healing
• Scarring

Intervention

Drug:
• Collagenase Santyl
Dermatome-induced skin wounds treated with drug active. Each subject serves as his own control receiving both treatments in parallel.
• Collagenase Santyl Vehicle
Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Complete Wound Closure Collagenase Santyl and Vehicle		21 days	No
Secondary	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.	9 Months	No