Long Term Follow Up to Determine the Effects of Collagenase SANTYL Ointment on Scar Formation

NCT01705860 | Completed

• 1 other identifier: 017-101-09-032
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will evaluate the long term effects on scar formation for dermatome-induced skin wounds treated with Collagenase Santyl® Ointment or vehicle (white petrolatum ointment) alone. The previous study, 017-101-09-001, utilized a small, experimental, cutaneous wound to evaluate both time to complete wound closure and quality of the resulting scar when Collagenase Santyl® Ointment was used to treat the wound.

Conditions

Follow up to Acute Wound Scar Study

Keywords

Collagen, collagenase, scar

Outcome Measures

Primary Outcomes (1)

• Scar Assessment

  Vancouver Scar Scale assessment of dermatome wounds previously treated with Santyl Ointment or White Petrolatum

  1 Day

Secondary Outcomes (1)

• Scar Quality

  1 Day

Study Arms (1)

Assessment

All subjects will receive same assessments.

Biological: Santyl

Interventions

Santyl BIOLOGICAL

Assessment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy adult volunteers who were previously treated in study 017-101-09-001 with Collagenase Santyl Ointment and Vehicle (white petrolatum ointment).

You may qualify if:

• Subjects will be considered qualified for enrollment if they participated in the Collagenase Santyl® Ointment Study 017 101-09-001 and provide written informed consent.
• The informed consent document must be read, signed, and dated by the suubject before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject. A photocopy of the signed informed consent document must be provided to the subject and the original signed document placed in the subject's chart.
• Subject participated in the 017-101-09-001 study and received at least one application of a test article, whether Collagenase Santyl® Ointment or White Petrolatum.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Healthpoint: lead

Study Sites (1)

Unknown Facility

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Collagenases

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Herbert B Slade, MD

  Healthpoint

  STUDY CHAIR

• Shai Rozen, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 12, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 15, 2013

Record last verified: 2013-04

Locations

US (1)