Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins Treatment

This study has suspended participant recruitment.
(Study suspended by decision strategically.)
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01426035
First received: May 9, 2011
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate cream in the treatment of superficial varicose veins


Condition Intervention Phase
VARICOSE VEINS
Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III of Safety and Efficacy Study of Topic Mucopolysaccharide Polysulfate Cream 5mg/g in the Superficial Varicose Veins Treatment

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy - Symptoms reduction [ Time Frame: Evaluation time: 15 days treatment ] [ Designated as safety issue: Yes ]
    The primary outcome measure will be evaluated for: Lesion area reduction, reduction of symptoms time and edema


Secondary Outcome Measures:
  • Efficacy - patient evaluation [ Time Frame: Evaluation time: 15 days treatment ] [ Designated as safety issue: No ]
    The secondary outcome measure will be measured by subjective opinion (daily register).


Estimated Enrollment: 76
Study Start Date: September 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GROUP 1 Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G
APLIED 4 TIMES/DAY AT LESION
Active Comparator: GROUP 2 Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G
APLIED 4 TIMES/DAY AT LESION

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be able to understand the study procedures, agree to participate, and give written consent.
  • Patients must be able to follow the study medication regimen.
  • Patients with inflammatory process in superficial veins for more than 72 hours.
  • Presence of symmetric lesions to compare one side to the other.

Exclusion Criteria:

  • Pregnancy or risk of pregnancy.
  • Lactation.
  • Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
  • Any alteration at other deep veins.
  • History of atopy or allergic diseases.
  • History of allergy to any component of the formulations.
  • Other conditions considered by the investigator as reasonable for non-eligibility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426035

Locations
Brazil
Medcin Instituto Da Pele
Osasco, São Paulo, Brazil
Sponsors and Collaborators
EMS
Investigators
Principal Investigator: FLAVIA ADDOR MEDCIN INSTITUTO DA PELE
Study Director: Felipe Pinho, MD EMS
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01426035     History of Changes
Other Study ID Numbers: MPSEMS0110_cream
Study First Received: May 9, 2011
Last Updated: March 1, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by EMS:
SUPERFICIAL VARICOSE VEINS

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014