Trial Outcomes & Findings for Effect of Collagenase on Healing and Scarring (NCT NCT00651820)

NCT ID: NCT00651820

Last Updated: 2011-06-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 28 participants
• Primary outcome timeframe: 21 days
• Results posted on: 2011-06-09

Participant Flow

Participant milestones

Measure	Rate of Wound Closure Collagenase Santyl vs. Vehicle 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 Study STARTED	28
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Rate of Wound Closure Collagenase Santyl vs. Vehicle 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 Study Lost to Follow-up	2

Baseline Characteristics

Effect of Collagenase on Healing and Scarring

Baseline characteristics by cohort

Measure	Rate of Wound Closure Collagenase Santyl vs. Vehicle n=28 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	37.6 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

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

Outcome measures

Measure	Collagenase Santyl Rate of Wound Closure n=28 Dermatome-induced wounds on Arms 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.	Vehicle Rate to Complete Wound Healing n=28 Dermatome-induced wounds on Arms 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.
Time to Complete Wound Closure Collagenase Santyl and Vehicle	12.9 Days Interval 6.0 to 26.0	13.0 Days Interval 8.0 to 26.0

SECONDARY outcome

Timeframe: 9 Months

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

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

Outcome measures

Measure	Collagenase Santyl Rate of Wound Closure n=28 Dermatome-induced wounds on Arms 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.	Vehicle Rate to Complete Wound Healing n=28 Dermatome-induced wounds on Arms 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.
Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle Stiffness	184.25 mmHg/mm Standard Deviation 37.47	174.05 mmHg/mm Standard Deviation 46.51
Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle Energy Absorption	72.6 mmHg/mm Standard Deviation 18.33	78.48 mmHg/mm Standard Deviation 24.96

Adverse Events

Rate of Wound Closure Collagenase Santyl vs. Vehicle

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure

Rate of Wound Closure Collagenase Santyl vs. Vehicle n=28 participants at risk 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.

Vascular disorders Brain Aneurysm

3.6% 1/28 • Number of events 1 • Adverse event data was collected over the 9 month period of the study 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.

Other adverse events

Measure	Rate of Wound Closure Collagenase Santyl vs. Vehicle n=28 participants at risk 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.
Skin and subcutaneous tissue disorders Erythema	7.1% 2/28 • Number of events 2 • Adverse event data was collected over the 9 month period of the study 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.
Skin and subcutaneous tissue disorders Rash	7.1% 2/28 • Number of events 2 • Adverse event data was collected over the 9 month period of the study 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.

Additional Information

Herbert B. Slade, M.D., FAAAI

Healthpoint, Ltd.

Phone: 817-900-4000

Email: bert.slade@healthpoint.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place