Effect of Collagenase on Healing and Scarring

Healthpoint

Status and phase: Completed; Phase 4

Conditions: Scarring; Impaired Wound Healing

Treatments: Drug: Collagenase Santyl Vehicle; Drug: Collagenase Santyl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651820

017 101 09 001

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Provide written informed consent
2. Willing to attend all required study visits

Exclusion criteria

1. Known hypersensitivity to Clostridial collagenase
2. Anticoagulants (blood thinners, including aspirin) within two weeks
3. Congenital skin disorder which affects keratinocytes, elastin, or collagen
4. Any dermatologic disease which may be aggravated or provoked by the wounding procedure
5. Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding
6. At risk of keloid or hypertrophic scar formation
7. Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed
8. Any skin disorder which causes delayed healing
9. Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome
10. 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

Collagenase Santyl Rate of Wound Closure

Experimental group

Description:

Dermatome-induced skin wounds treated with drug active (collagenase).

Treatment:

Drug: Collagenase Santyl

Vehicle Rate of Wound Closure

Placebo Comparator group

Description:

Dermatome-induced skin wounds treated with Vehicle alone.

Treatment:

Drug: Collagenase Santyl Vehicle