ScarringPhase 4NCT00651820
Effect of Collagenase on Healing and Scarring
A Phase 4 study testing Collagenase Santyl in people with Scarring and Impaired Wound Healing, run by Healthpoint at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Scarring, Impaired Wound Healing
- What is being tested?
- Collagenase Santyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written informed consent
- Willing to attend all required study visits
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas
About this study
Official title: A Randomized, Double-blind, Paired-Comparison of the Effect of Collagenase Santyl® Ointment on Healing and Scarring Characteristics of 600μm Dermatome Wounds
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.
- Conditions
- Scarring, Impaired Wound Healing
- Being tested
- Collagenase Santyl, Collagenase Santyl Vehicle
- Keywords
- wound healing, scarring, collagenase, Santyl
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase SantylDrug
Dermatome-induced skin wounds treated with drug active.
Each subject serves as his own control receiving both treatments in parallel.
Collagenase Santyl VehicleDrug
Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.
| Study group | Role | What they receive |
|---|---|---|
| Collagenase Santyl Rate of Wound Closure | Experimental | Dermatome-induced skin wounds treated with drug active (collagenase). Receives: Drug: Collagenase Santyl |
| Vehicle Rate of Wound Closure | Placebo comparator | Dermatome-induced skin wounds treated with Vehicle alone. Receives: Drug: Collagenase Santyl Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Wound Closure Collagenase Santyl and Vehicle
Measured: 21 days
Secondary outcomes (1)
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.
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ScarringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Herbert B Slade, MD, Study director, Healthpoint
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651820
- Sponsor's protocol ID
- 017 101 09 001
- Status last verified
- Jun 2011
- First submitted
- 20 Mar 2008
- Last updated
- 9 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Paired-Comparison of the Effect of Collagenase Santyl® Ointment on Healing and Scarring Characteristics of 600μm Dermatome Wounds
- ClinicalTrials.gov ID
- NCT00651820
- Acronym / sponsor ID
- 017 101 09 001
- Conditions
- Scarring, Impaired Wound Healing
- Keywords
- wound healing, scarring, collagenase, Santyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Posted 26 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagenase Santyl Rate of Wound Closure | Experimental | Drug: Collagenase SantylDermatome-induced skin wounds treated with drug active (collagenase). |
| Vehicle Rate of Wound Closure | Placebo comparator | Drug: Collagenase Santyl VehicleDermatome-induced skin wounds treated with Vehicle alone. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provide written informed consent
- Willing to attend all required study visits
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagenase SantylDermatome-induced skin wounds treated with drug active. Each subject serves as his own control receiving both treatments in parallel. | Drug | Collagenase Santyl Rate of Wound Closure |
| Collagenase Santyl VehicleDermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel. | Drug | Vehicle Rate of Wound Closure |
Primary outcome
Time to Complete Wound Closure Collagenase Santyl and Vehicle
Time frame: 21 days
1 secondary outcome
Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle
Time frame: 9 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Scarring
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
RecruitingPhase 2
Tirzepatide for Treatment of CCCA
Central Centrifugal Cicatricial Alopecia (CCCA)
Recruiting
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Skin Graft Scar
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert B Slade, MD study director
Healthpoint
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collagenase Santyl in people with Scarring and Impaired Wound Healing, run by Healthpoint at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Complete Wound Closure Collagenase Santyl and Vehicle (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2011.