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

EMS

Status and phase: Withdrawn; Phase 3

Conditions: VARICOSE VEINS

Treatments: Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G

Study type: Interventional

Funder types: Industry

Identifiers

NCT01203397

MPSEMS0110

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

GROUP 2

Active Comparator group

Treatment:

Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G

GROUP 1

Experimental group

Treatment:

Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G