Phase 4 N=28 Randomized Quadruple-blind Basic Science

Effect of Collagenase on Healing and Scarring

Scarring · Impaired Wound Healing

Bottom Line

View on ClinicalTrials.gov: NCT00651820 ↗

Enrolled (actual)

Serious AEs

3.6%

Results posted

Jan 2011

Primary outcome: Primary: Time to Complete Wound Closure Collagenase Santyl and Vehicle — 12.9; 13.0 Days — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Collagenase Santyl (Drug); Collagenase Santyl Vehicle (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Healthpoint
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Complete Wound Closure Collagenase Santyl and Vehicle	12.9; 13.0	<0.05 sig
SECONDARY Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle	184.25; 174.05; 72.6; 78.48	<0.05 sig

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.

Eligibility Criteria

Inclusion Criteria

Provide written informed consent
Willing to attend all required study visits

Exclusion Criteria

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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00651820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.