Varicose VeinsPhase 2TPTNCT04203043
The Prevstain Trial
A Phase 2 study testing Pycnogenol Oral Product in people with Varicose Veins, run by University of Sao Paulo General Hospital.
Trial summary
To evaluate whether oral supplementation with Pycnogenol (Flebon®) can interfere with skin hyperpigmentation after polidocanol foam sclerotherapy in patients with mild to moderate chronic venous insufficiency (CEAP C2 and C3) compared with the use of Placebo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Pycnogenol Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2020to 28 Dec 2021
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participants, non-pregnant, aged ≥18 years.
- Phototype Fitzpatrick II to IV
- Participant with mild to moderate chronic venous insufficiency (classification C2 and C3 of the clinical criterion CEAP classification).
- Participant who underwent treatment of the great saphenous vein
- and. Indication for performing lower limb sclerotherapy followed by elastopression for 7 days.
- With indication for procedure by 1% polidocanol sclerotherapy
- Demonstrate understanding of procedures, study restrictions and willingness to participate as evidenced by written informed consent and attendance of all scheduled visits
- Good overall mental and health with, in the opinion of the investigator or medically qualified designee, no clinically significant and relevant abnormalities in medical history or upon physical examination.
Who cannot join
- The. Pregnancy or intention to become pregnant during the study or breastfeeding women.
- Any history of significant dermatological conditions or diseases or medical conditions known to alter skin appearance or physiological response (eg, diabetes, heart failure, hypothyroidism, or hyperthyroidism), which could, in the opinion of the Investigator, prevent and / or interfere with the assessment of the reaction of the test site.
- Active acne (local or widespread) that may interfere with study results.
- Participants currently using any medication, which, in the opinion of the investigator, may affect the evaluation of the study product or subject the participant to excessive risk.
- Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticosteroids up to 2 weeks before the screening visit.
- Oral or topical treatment with vitamin A or retinoic acid and / or its derivatives up to 1 month before the screening visit.
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- Have participated in any clinical study within the last 12 months prior to the start of the study;
- Any clinical and / or laboratory alteration that, in the Investigator's opinion, may interfere with the participant's safety.
- Use of anticoagulant or antiplatelet agent
- BMI greater than 40 kg / m² Uncontrolled diabetes or hypertension
- Recent thrombosis (less than 6 months from inclusion)
- no Participants with a history of polyamide or elastane allergy
About this study
Official title: Double Blind Randomized Clinical Trial Comparing Pycnogenol Versus Placebo for Pigmentation Prevention After Treatment With Varicose Veins With Foam Sclerotherapy
To evaluate whether oral supplementation with Pycnogenol (Flebon®) can interfere with skin hyperpigmentation after polidocanol foam sclerotherapy in patients with mild to moderate chronic venous insufficiency (CEAP C2 and C3) compared with the use of Placebo.
Read the detailed description
A randomized double-blind study with research centers in the state of São Paulo (Hospital das Clínicas de São Paulo (HC-SP)) is proposed. Treatment groups: Group 1: Elastic stockings + FlebonGroup 2: Use of elastic socks + Placebo de Flebon.1 Visit 1 - Screening and Selection (D-15) • Evaluation of inclusion and non-inclusion criteria • FICT signature • Clinical evaluation • Aberdeen questionnaire (without schematic design) • Randomization • Dispensation of medication (placebo and Pycnogenol) • Dismissal of use diary 2. Visit 02 D0 - Initiation of treatment (+/- 2 days) • Performing the procedure by Sclerotherapy • Record of adverse events • Pre-sclerotherapy photographic record • Clinical evaluation • investigational product (placebo and Pycnogenol) • Dismissal of new use diary (elastic stockings and investigational product) • Withdrawal criteria • Visit 03 - D7 - Return of 7 days (+/- 2 days) • Evaluation of withdrawal criteria • Evaluated adherence to treatment by use diary • Return of control (eventual drainage) • Record of adverse events • Clinical evaluationVisit 04 - D30 - Return 30 days after visit 2 (+/- 2 days) • Treatment adherence assessment by use diary • Photographic control I • Hyperpigmentation scale • Pigment size assessment, if any • Record of adverse events • Assessment of withdrawal criteria • Assessment clinical • Investigational Product Dispensation (Placebo and Pycnogenol) • New Usage Diary DispensationView 05- D60 - Return 60 Days After Sight 3 (+/- 2 days) • Usage Diary Treatment Adherence Assessment • Photographic Control II • Hyperpigmentation Scale • Pigment size assessment, if any • Record of adverse events • Assessment of withdrawal criteria • Assessment • Dispensation of medication (placebo and Pycnogenol) • Dispensation of new use diaryVisit 06 -D90 - Return 90 days after sight 04 (+/- 2 days) • Evaluation of treatment adherence by use diary • Evaluation of criteria • Photographic control III •Pigment size assessment, if any • Aberdeen questionnaire application (without schematic drawing) • Medication suspension • Hyperpigmentation scale • Adverse event recording • Research participant satisfaction rating • Clinical assessmentPhotographic recording of the legs will be performed before 30, 60 and 90 days in 03 (three) incidences and evaluated by 01 blind observer. The photographic records will be made by camera following the same parameters, namely: 60 cm distance to 50 cm from the ground, not using flash, with artificial lighting (ceiling light), without zoom. All generated images will be archived in JPEG (Joint Photographic File Format) format. Images must be downloaded within 5 days of photographic registration and inserted into All images should be encoded as follows: IDENTIFICATION OF PARTICIPANTS + DATE OF PHOTOGRAPH REGISTRATION CO (00/00/0000) + VISIT. In addition, a sticker with the research participant's initials and date of photograph registration should be visible to the image. The blinded study medium will evaluate all photographs at the end of the study, making a comparison between them to inform the presence and the evolution of hyperpigmentation due to foam sclerotherapy, when they occur.For this, the Torok Hyperpigmentation Scale will be applied at D 30, D 60 and D90.
- Conditions
- Varicose Veins
- Being tested
- Pycnogenol Oral Product, Placebo
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pycnogenol Oral ProductDrug
pycnogenol use to prevent hyper pigmentation after foam sclerotherapy
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Pycnogenol oral product to prevent Hyperpigmentation | Active comparator | Evaluate hyperpigmentation post foam sclerotherapy with placebo versus pycnogenol use Receives: Drug: Pycnogenol Oral Product |
| Placebo to prevent hyperpigmentation | Placebo comparator | Evaluate hyperpigmentation post foam sclerotherapy with placebo versus pycnogenol use Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
photographic evaluation of the presence or absence of skin hyperpigmentation after foam sclerotherapy
To evaluate the impact of Pycnogenol (Flebon®) use on skin hyperpigmentation after sclerotherapy procedure in relation to placebo group, according to the presence or absence of hyperpigmentation.Hyperpigmentation will be assessed through standardized photographs taken by the study researchers and evaluated by a blinded dermatologist in the study. The answer will be dichotomous, yes or no.
Measured: 90 days
Secondary outcomes (5)
The use of Pycnogenol (Flebon®) triggers change cutaneous pigmentation;
The degree of pigmentation involvement will be assessed using the Hyperpigmentation Scale (Torok) by a blinded dermatologist in the study after 30, 60 and 90 days of treatment.
Measured: 90 days
The use of Pycnogenol (Flebon®) triggers a change skin pigmentation.
The size of the pigmentation will be evaluated by the use of a conventional standardized ruler, considering the largest pigmentation axis, verified in millimeters, after 30, 60 and 90 days of treatment.
Measured: 90 days
The use of Pycnogenol (Flebon®) change the signs and symptoms of chronic venous insufficiency by applying a CVI-specific quality of life questionnaire.
Improvement of signs and symptoms of chronic venous insufficiency will be assessed by applying the Aberdeen questionnaire (without schematic design) at baseline and after 90 days of treatment.
Measured: 90 days
the degree of patient satisfaction with the use of Pycnogenol (Flebon®) regarding the skin aspect of the region submitted to the procedure;
The degree of patient satisfaction will be made subjectively by the study participants through a scale from 0 to 6, 0 being totally dissatisfied and 6 fully satisfied after 90 days of treatment.
Measured: 90 days
pycnogenol side effects
report any type of adverse event
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start28 Feb 2020 (estimated)
- Primary completion28 Mar 2020 (estimated)
- Study completion28 Dec 2021 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NELSON DE LUCCIA, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203043
- Sponsor's protocol ID
- 08890918.0.0000.0068
- Acronym
- TPT
- Status last verified
- Feb 2020
- First submitted
- 28 Nov 2019
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Clinical Trial Comparing Pycnogenol Versus Placebo for Pigmentation Prevention After Treatment With Varicose Veins With Foam Sclerotherapy
- ClinicalTrials.gov ID
- NCT04203043
- Acronym / sponsor ID
- TPT / 08890918.0.0000.0068
- Conditions
- Varicose Veins
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 28 Feb 2020 (estimated)
- Primary completion
- 28 Mar 2020 (estimated)
- Study completion
- 28 Dec 2021 (estimated)
- First posted
- 18 Dec 2019 (actual)
- 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.
To evaluate whether oral supplementation with Pycnogenol (Flebon®) can interfere with skin hyperpigmentation after polidocanol foam sclerotherapy in patients with mild to moderate chronic venous insufficiency (CEAP C2 and C3) compared with the use of Placebo.
Detailed description
A randomized double-blind study with research centers in the state of São Paulo (Hospital das Clínicas de São Paulo (HC-SP)) is proposed. Treatment groups: Group 1: Elastic stockings + FlebonGroup 2: Use of elastic socks + Placebo de Flebon.1 Visit 1 - Screening and Selection (D-15) • Evaluation of inclusion and non-inclusion criteria • FICT signature • Clinical evaluation • Aberdeen questionnaire (without schematic design) • Randomization • Dispensation of medication (placebo and Pycnogenol) • Dismissal of use diary 2. Visit 02 D0 - Initiation of treatment (+/- 2 days) • Performing the procedure by Sclerotherapy • Record of adverse events • Pre-sclerotherapy photographic record • Clinical evaluation • investigational product (placebo and Pycnogenol) • Dismissal of new use diary (elastic stockings and investigational product) • Withdrawal criteria • Visit 03 - D7 - Return of 7 days (+/- 2 days) • Evaluation of withdrawal criteria • Evaluated adherence to treatment by use diary • Return of control (eventual drainage) • Record of adverse events • Clinical evaluationVisit 04 - D30 - Return 30 days after visit 2 (+/- 2 days) • Treatment adherence assessment by use diary • Photographic control I • Hyperpigmentation scale • Pigment size assessment, if any • Record of adverse events • Assessment of withdrawal criteria • Assessment clinical • Investigational Product Dispensation (Placebo and Pycnogenol) • New Usage Diary DispensationView 05- D60 - Return 60 Days After Sight 3 (+/- 2 days) • Usage Diary Treatment Adherence Assessment • Photographic Control II • Hyperpigmentation Scale • Pigment size assessment, if any • Record of adverse events • Assessment of withdrawal criteria • Assessment • Dispensation of medication (placebo and Pycnogenol) • Dispensation of new use diaryVisit 06 -D90 - Return 90 days after sight 04 (+/- 2 days) • Evaluation of treatment adherence by use diary • Evaluation of criteria • Photographic control III •Pigment size assessment, if any • Aberdeen questionnaire application (without schematic drawing) • Medication suspension • Hyperpigmentation scale • Adverse event recording • Research participant satisfaction rating • Clinical assessmentPhotographic recording of the legs will be performed before 30, 60 and 90 days in 03 (three) incidences and evaluated by 01 blind observer. The photographic records will be made by camera following the same parameters, namely: 60 cm distance to 50 cm from the ground, not using flash, with artificial lighting (ceiling light), without zoom. All generated images will be archived in JPEG (Joint Photographic File Format) format. Images must be downloaded within 5 days of photographic registration and inserted into All images should be encoded as follows: IDENTIFICATION OF PARTICIPANTS + DATE OF PHOTOGRAPH REGISTRATION CO (00/00/0000) + VISIT. In addition, a sticker with the research participant's initials and date of photograph registration should be visible to the image. The blinded study medium will evaluate all photographs at the end of the study, making a comparison between them to inform the presence and the evolution of hyperpigmentation due to foam sclerotherapy, when they occur.For this, the Torok Hyperpigmentation Scale will be applied at D 30, D 60 and D90.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pycnogenol oral product to prevent Hyperpigmentation | Active comparator | Drug: Pycnogenol Oral ProductEvaluate hyperpigmentation post foam sclerotherapy with placebo versus pycnogenol use |
| Placebo to prevent hyperpigmentation | Placebo comparator | Other: PlaceboEvaluate hyperpigmentation post foam sclerotherapy with placebo versus pycnogenol use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female participants, non-pregnant, aged ≥18 years.
- Phototype Fitzpatrick II to IV
- Participant with mild to moderate chronic venous insufficiency (classification C2 and C3 of the clinical criterion CEAP classification).
- Participant who underwent treatment of the great saphenous vein
- and. Indication for performing lower limb sclerotherapy followed by elastopression for 7 days.
Key exclusion criteria (12 listed)
- The. Pregnancy or intention to become pregnant during the study or breastfeeding women.
- Any history of significant dermatological conditions or diseases or medical conditions known to alter skin appearance or physiological response (eg, diabetes, heart failure, hypothyroidism, or hyperthyroidism), which could, in the opinion of the Investigator, prevent and / or interfere with the assessment of the reaction of the test site.
- Active acne (local or widespread) that may interfere with study results.
- Participants currently using any medication, which, in the opinion of the investigator, may affect the evaluation of the study product or subject the participant to excessive risk.
- Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticosteroids up to 2 weeks before the screening visit.
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 |
|---|---|---|
| Pycnogenol Oral Productpycnogenol use to prevent hyper pigmentation after foam sclerotherapy | Drug | Pycnogenol oral product to prevent Hyperpigmentation |
| PlaceboPlacebo | Other | Placebo to prevent hyperpigmentation |
Primary outcome
photographic evaluation of the presence or absence of skin hyperpigmentation after foam sclerotherapy
Time frame: 90 days
To evaluate the impact of Pycnogenol (Flebon®) use on skin hyperpigmentation after sclerotherapy procedure in relation to placebo group, according to the presence or absence of hyperpigmentation.Hyperpigmentation will be assessed through standardized photographs taken by the study researchers and evaluated by a blinded dermatologist in the study. The answer will be dichotomous, yes or no.
5 secondary outcomes
The use of Pycnogenol (Flebon®) triggers change cutaneous pigmentation;
Time frame: 90 days
The use of Pycnogenol (Flebon®) triggers a change skin pigmentation.
Time frame: 90 days
The use of Pycnogenol (Flebon®) change the signs and symptoms of chronic venous insufficiency by applying a CVI-specific quality of life questionnaire.
Time frame: 90 days
the degree of patient satisfaction with the use of Pycnogenol (Flebon®) regarding the skin aspect of the region submitted to the procedure;
Time frame: 90 days
pycnogenol side effects
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pycnogenol Oral Product in people with Varicose Veins, run by University of Sao Paulo General Hospital.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
photographic evaluation of the presence or absence of skin hyperpigmentation after foam sclerotherapy (time frame: 90 days). 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 7 Feb 2020.