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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagenase Santyl Rate of Wound Closure | Experimental | Dermatome-induced skin wounds treated with drug active (collagenase). |
|
| Vehicle Rate of Wound Closure | Placebo Comparator | Dermatome-induced skin wounds treated with Vehicle alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagenase Santyl | Drug | Dermatome-induced skin wounds treated with drug active. Each subject serves as his own control receiving both treatments in parallel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Wound Closure Collagenase Santyl and Vehicle | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert B Slade, MD | Healthpoint | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Complete Wound Closure Collagenase Santyl and Vehicle | Analysis was performed on all subjects as intent-to-treat (ITT). | Posted | Mean | 95% Confidence Interval | Days | 21 days | Dermatome-induced wounds on Arms | Participants |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brain Aneurysm | Vascular disorders | MedDRA (11.0) | Systematic Assessment | The 1 SAE (brain aneurysm) was reported as severe and was unrelated to the test articles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment | Wound redness (erythema)- Investigator specified Right Arm for 1 subject, which was treated with Vehicle. Investigator did not specify arm for the second subject with erythema, so causative agent could not be determined. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Herbert B. Slade, M.D., FAAAI | Healthpoint, Ltd. | 817-900-4000 | bert.slade@healthpoint.com |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Collagenase Santyl Vehicle | Drug | Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel. |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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|
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| 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. | Analysis performed on Intent-to-Treat (ITT) population | Posted | Mean | Standard Deviation | mmHg/mm | 9 Months | Dermatome-induced wounds on Arms | Participants |
|
|
|
|
| 1 |
| 28 |
| 4 |
| 28 |
|
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment | For 1 subject the Investigator did not specify which arm developed the rash, so unable to determine if Collagenase Santyl or its vehicle was causative agent. For the other subject the Investigator specified that both arms developed a rash. |
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| t-test, 2 sided |
| <0.05 |
| Mean Difference (Final Values) |
| -5.88 |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |