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Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers

This study has suspended participant recruitment.
Information provided by:
Azidus Brasil Identifier:
First received: June 17, 2008
Last updated: October 22, 2010
Last verified: February 2008

Skin ulcers can be defined as open injuries, loss of substances with the skin or mucous tissue, caused by disintegration and tissue necrosis. Chronic skin ulcer is any injury that heal in a period not less than 6 weeks. Several etiological causes for the emergence of skin ulcers. Around 73% are venous, arterial are 8%, 3% are diabetic, 2% are traumatic and 14% are from other causes.

Clinical studies show that collagenase is an effective drug and presents high tolerabildade in the treatment of ulcerative burns and injuries of various etiologies. Evidence show statistically significant reduction of inflammation, the formation of granulation tissue, decrease in injuries and reepitelization.

Condition Intervention Phase
Biological: collagenase (IRUXOL)
Biological: collagenase (Kollagenase)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of Non Inferiority of Product Kollagenase ®, Manufactured by Laboratory Cristália When Compared With Iruxol ®, Manufactured by Abbott Laboratory, in the Treatment of Cutaneous Ulcers

Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • Primary: Non-inferiority based on efficiency that will be evaluated by the general improvement of the injury; Secondary: tolerability assessed by the incidence of adverse events. [ Time Frame: healing ]

Estimated Enrollment: 66
Study Start Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients treated with collagenase (IRUXOL)
Biological: collagenase (IRUXOL)
patients will be treated with collagenase one time per day.
Experimental: 2
patients treated with collagenase (Kollagenase)
Biological: collagenase (Kollagenase)
patients will be treated with collagenase one time per day.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients of both sexes aged over 18 years
  • people with skin ulcers of the lower limbs for at least 3 months

Exclusion Criteria:

  • Lesion with a diameter larger than 12 cm ²
  • injury over 2 years of evolution; injury infected
  • neoplastic lesions in activity
  • poorly controlled diabetes mellitus
  • HAS poorly controlled
  • signs of ischemia in the limb
  • not offset any disease
  • allergic to components of formula
  • urticaria
  • pregnancy
  • breastfeeding
  • emotional disturbance
  Contacts and Locations
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Please refer to this study by its identifier: NCT00701974

Lal Clinica
Valinhos, Sao Paulo, Brazil
Sponsors and Collaborators
Azidus Brasil
  More Information

Responsible Party: Alexandre Frederico, LAL Clinica Identifier: NCT00701974     History of Changes
Other Study ID Numbers: COLCRI0208
Study First Received: June 17, 2008
Last Updated: October 22, 2010

Keywords provided by Azidus Brasil:
Non-inferiority based on efficiency

Additional relevant MeSH terms:
Skin Ulcer
Pathologic Processes
Skin Diseases processed this record on May 22, 2017