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

Phase III of Safety and Efficacy Study of Topic Mucopolysaccharide Polysulfate Cream 5mg/g in the Superficial Varicose Veins Treatment

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01426035

Enrollment

Registered

2011-08-30

Start date

2014-09-30

Completion date

2015-02-28

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

VARICOSE VEINS

Keywords

SUPERFICIAL VARICOSE VEINS

Brief summary

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

Interventions

DRUGTOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G

APLIED 4 TIMES/DAY AT LESION

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026