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

NCT ID: NCT01426035

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-02-28

Brief Summary

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

Detailed Description

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Conditions

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VARICOSE VEINS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GROUP 1

Group Type EXPERIMENTAL

TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G

Intervention Type DRUG

APLIED 4 TIMES/DAY AT LESION

GROUP 2

Group Type ACTIVE_COMPARATOR

TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G

Intervention Type DRUG

APLIED 4 TIMES/DAY AT LESION

Interventions

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TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G

APLIED 4 TIMES/DAY AT LESION

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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FLAVIA ADDOR

Role: PRINCIPAL_INVESTIGATOR

Medcin Instituto da Pele

Felipe Pinho, MD

Role: STUDY_DIRECTOR

EMS

Locations

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Medcin Instituto Da Pele

Osasco, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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MPSEMS0110_cream

Identifier Type: -

Identifier Source: org_study_id

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