VARICOSE VEINSPhase 3NCT01426035
Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins Treatment
A Phase 3 study testing TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G in people with VARICOSE VEINS, run by EMS at 1 site in Brazil.
Trial summary
Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate cream in the treatment of superficial varicose veins Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- VARICOSE VEINS
- What is being tested?
- TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Feb 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Phase III of Safety and Efficacy Study of Topic Mucopolysaccharide Polysulfate Cream 5mg/g in the Superficial Varicose Veins Treatment
Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate cream in the treatment of superficial varicose veins
- Conditions
- VARICOSE VEINS
- Being tested
- TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G
- Keywords
- SUPERFICIAL VARICOSE VEINS
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/GDrug
APLIED 4 TIMES/DAY AT LESION
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Experimental | Not described Receives: Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G |
| GROUP 2 | Active comparator | Not described Receives: Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Symptoms reduction
The primary outcome measure will be evaluated for: Lesion area reduction, reduction of symptoms time and edema
Measured: Evaluation time: 15 days treatment
Secondary outcomes (1)
Efficacy - patient evaluation
The secondary outcome measure will be measured by subjective opinion (daily register).
Measured: Evaluation time: 15 days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startSep 2014
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VARICOSE VEINSStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- FLAVIA ADDOR, Principal investigator, Medcin Instituto da PeleFelipe Pinho, MD, Study director, EMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426035
- Sponsor's protocol ID
- MPSEMS0110_cream
- Status last verified
- Feb 2021
- First submitted
- 9 May 2011
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III of Safety and Efficacy Study of Topic Mucopolysaccharide Polysulfate Cream 5mg/g in the Superficial Varicose Veins Treatment
- ClinicalTrials.gov ID
- NCT01426035
- Acronym / sponsor ID
- MPSEMS0110_cream
- Conditions
- VARICOSE VEINS
- Keywords
- SUPERFICIAL VARICOSE VEINS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate cream in the treatment of superficial varicose veins
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Experimental | Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G |
| GROUP 2 | Active comparator | Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/GAPLIED 4 TIMES/DAY AT LESION | Drug | GROUP 1, GROUP 2 |
Primary outcome
Efficacy - Symptoms reduction
Time frame: Evaluation time: 15 days treatment
The primary outcome measure will be evaluated for: Lesion area reduction, reduction of symptoms time and edema
1 secondary outcome
Efficacy - patient evaluation
Time frame: Evaluation time: 15 days treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FLAVIA ADDOR principal investigator
Medcin Instituto da Pele
Felipe Pinho, MD study director
EMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G in people with VARICOSE VEINS, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - Symptoms reduction (time frame: Evaluation time: 15 days treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.