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

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ClinicalTrials.gov Identifier: NCT00701974
Recruitment Status : Suspended
First Posted : June 19, 2008
Last Update Posted : October 25, 2010
Sponsor:
Information provided by:
Azidus Brasil

Brief Summary:

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 or disease Intervention/treatment Phase
Ulcers Biological: collagenase (IRUXOL) Biological: collagenase (Kollagenase) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : February 2008
Actual Primary Completion Date : February 2008

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701974


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

Responsible Party: Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT00701974     History of Changes
Other Study ID Numbers: COLCRI0208
colcri0208
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: February 2008

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

Additional relevant MeSH terms:
Ulcer
Skin Ulcer
Pathologic Processes
Skin Diseases