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

Primary Purpose

VARICOSE VEINS

Status

Withdrawn

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G

About this trial

This is an interventional treatment trial for VARICOSE VEINS focused on measuring SUPERFICIAL VARICOSE VEINS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medcin Instituto Da Pele

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

GROUP 2

GROUP 1

Arm Description

Outcomes

Primary Outcome Measures

Efficacy - Symptoms reduction

The primary outcome measure will be evaluated for: Lesion area reduction, reduction of symptoms time and edema.

Secondary Outcome Measures

Efficacy - patient evaluation

The secondary outcome measure will be measured by subjective opinion (daily register.

Full Information

NCT ID

NCT01203397

First Posted

September 15, 2010

Last Updated

February 23, 2021

Sponsor

EMS

1. Study Identification

Unique Protocol Identification Number

NCT01203397

Brief Title

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

Official Title

PHASE III OF SAFETY AND EFFICACY STUDY OF TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G IN THE SUPERFICIAL VARICOSE VEINS TREATMENT

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor decision

Study Start Date

September 2014 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMS

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

VARICOSE VEINS

Keywords

SUPERFICIAL VARICOSE VEINS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GROUP 2

Arm Type

Active Comparator

Arm Title

GROUP 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G

Intervention Description

APLIED 4 TIMES/DAY AT LESION

Primary Outcome Measure Information:

Title

Efficacy - Symptoms reduction

Description

The primary outcome measure will be evaluated for: Lesion area reduction, reduction of symptoms time and edema.

Time Frame

Evaluation time: 3 - 7 - 10 and 15 days

Secondary Outcome Measure Information:

Title

Efficacy - patient evaluation

Description

The secondary outcome measure will be measured by subjective opinion (daily register.

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

FLAVIA ADDOR

Organizational Affiliation

Medcin Instituto da Pele

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Felipe Pinho, MD

Organizational Affiliation

EMS

Official's Role

Study Director

Facility Information:

Facility Name

Medcin Instituto Da Pele

City

Osasco

State/Province

SÃO Paulo

ZIP/Postal Code

060323-000

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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