Effect of Collagenase on Healing and Scarring

• Sponsor: Healthpoint (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00651820
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Scarring; Impaired Wound Healing	Drug: Collagenase Santyl; Drug: Collagenase Santyl Vehicle	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• 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 Start Date: Apr 1, 2008
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Collagenase Santyl Rate of Wound Closure Dermatome-induced skin wounds treated with drug active (collagenase).	Drug: Collagenase Santyl; Dermatome-induced skin wounds treated with drug active. Each subject serves as his own control receiving both treatments in parallel.
Placebo Comparator: Vehicle Rate of Wound Closure Dermatome-induced skin wounds treated with Vehicle alone.	Drug: Collagenase Santyl Vehicle; Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.

Outcome Measures

Primary Outcome Measures

1. Time to Complete Wound Closure Collagenase Santyl and Vehicle [21 days]

Secondary Outcome Measures

1. Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle [9 Months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Southwestern Medical Center	Dallas	Texas	United States

Sponsors and Collaborators

• Healthpoint

Investigators

• Study Director: Herbert B Slade, MD, Healthpoint

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00651820
• Other Study ID Numbers: 017 101 09 001
• First Posted: Apr 3, 2008
• Last Update Posted: Jun 9, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: wound healing; scarring; collagenase; Santyl
• Additional relevant MeSH terms: Cicatrix

Study Results

Participant Flow

Arm/Group Title	Rate of Wound Closure Collagenase Santyl vs. Vehicle
Arm/Group Description	Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
Period Title: Overall Study
STARTED	28
COMPLETED	26
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Rate of Wound Closure Collagenase Santyl vs. Vehicle
Arm/Group Description	Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
Overall Participants	28
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	28 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.6 (8.2)
Sex: Female, Male (Count of Participants)
Female	18 64.3%
Male	10 35.7%
Region of Enrollment (participants) [Number]
United States	28 100%

Outcome Measures

1. Primary Outcome

Title	Time to Complete Wound Closure Collagenase Santyl and Vehicle
Time Frame	21 days

Outcome Measure Data

Analysis Population Description

Analysis was performed on all subjects as intent-to-treat (ITT).

Arm/Group Title	Collagenase Santyl Rate of Wound Closure	Vehicle Rate to Complete Wound Healing
Arm/Group Description	Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.	Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
Measure Participants	28	28
Measure Dermatome-induced wounds on Arms	28	28
Mean (95% Confidence Interval) [Days]	12.9	13.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Collagenase Santyl Rate of Wound Closure, Vehicle Rate to Complete Wound Healing
	Comments	Each subject served as their own control, each receiving duplicate dermatome-induced wounds with 1 wound treated with active drug and the other treated with vehicle. Mean time to wound closure was calculated for the wounds treated with drug, the wounds treated with vehicle, and an over-all mean time to wound closure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Paired-Prentice Wilcoxon (PPW)
	Comments	Time to complete wound closure Drug(T1)and Vehicle(T2)Hypothesis, Ho: T1=T2,using paired Prentice-Wilcoxon at significant level of 5%, 2-sided.

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Analysis performed on Intent-to-Treat (ITT) population

Arm/Group Title	Collagenase Santyl Rate of Wound Closure	Vehicle Rate of Wound Closure
Arm/Group Description	Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.	Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
Measure Participants	28	28
Measure Dermatome-induced wounds on Arms	28	28
Stiffness	184.25 (37.47)	174.05 (46.51)
Energy Absorption	72.6 (18.33)	78.48 (24.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Collagenase Santyl Rate of Wound Closure, Vehicle Rate to Complete Wound Healing
	Comments	Stiffness: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10.20
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Collagenase Santyl Rate of Wound Closure, Vehicle Rate to Complete Wound Healing
	Comments	Energy Absorption: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.88
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse event data was collected over the 9 month period of the study
Adverse Event Reporting Description	Adverse events were captured, but the Investigator did not always capture which arm exhibited the adverse event, so no in depth analysis could be performed. Of the 2 subjects whose adverse event was probably related to test article (as designated by the Investigator), only 1 had the arm designated and that arm was treated with vehicle.
Arm/Group Title	Rate of Wound Closure Collagenase Santyl vs. Vehicle
Arm/Group Description	Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
All Cause Mortality
	Rate of Wound Closure Collagenase Santyl vs. Vehicle
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Rate of Wound Closure Collagenase Santyl vs. Vehicle
	Affected / at Risk (%)	# Events
Total	1/28 (3.6%)
Vascular disorders
Brain Aneurysm	1/28 (3.6%)	1
Other (Not Including Serious) Adverse Events
	Rate of Wound Closure Collagenase Santyl vs. Vehicle
	Affected / at Risk (%)	# Events
Total	4/28 (14.3%)
Skin and subcutaneous tissue disorders
Erythema	2/28 (7.1%)	2
Rash	2/28 (7.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.