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

Phase 3

Withdrawn

• Conditions: VARICOSE VEINS
• Interventions: Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G

• Registration Number: NCT01426035
• Lead Sponsor: EMS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-30
• Study Start: 2014-09
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP 2	TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G	-
GROUP 1	TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G	-

Primary Outcome Measures

Name	Time	Method
Efficacy - Symptoms reduction	Evaluation time: 15 days treatment	The primary outcome measure will be evaluated for: Lesion area reduction, reduction of symptoms time and edema

Secondary Outcome Measures

Name	Time	Method
Efficacy - patient evaluation	Evaluation time: 15 days treatment	The secondary outcome measure will be measured by subjective opinion (daily register).

Trial Locations

Locations (1)

Medcin Instituto Da Pele; 🇧🇷 Osasco, São Paulo, Brazil