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

Sponsor:	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:	NCT00701974

Purpose

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
Ulcers	Biological: collagenase (IRUXOL) Biological: collagenase (Kollagenase)	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Collagenase

U.S. FDA Resources

Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

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 ] [ Designated as safety issue: Yes ]

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701974

Locations

Brazil
Lal Clinica
Valinhos, Sao Paulo, Brazil

Sponsors and Collaborators

L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

More Information

No publications provided

Responsible Party:	Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier:	NCT00701974 History of Changes
Other Study ID Numbers:	COLCRI0208, colcri0208
Study First Received:	June 17, 2008
Last Updated:	October 22, 2010
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Non-inferiority based on efficiency

Additional relevant MeSH terms:

Skin Ulcer
Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012