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To evaluate whether oral supplementation with Pycnogenol (FlebonĀ®) 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.
A randomized double-blind study with research centers in the state of SĆ£o Paulo (Hospital das ClĆnicas de SĆ£o 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 ā¢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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pycnogenol oral product to prevent Hyperpigmentation | Active Comparator | Evaluate hyperpigmentation post foam sclerotherapy with placebo versus pycnogenol use |
|
| Placebo to prevent hyperpigmentation | Placebo Comparator | Evaluate hyperpigmentation post foam sclerotherapy with placebo versus pycnogenol use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pycnogenol Oral Product | Drug | pycnogenol use to prevent hyper pigmentation after foam sclerotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| photographic evaluation of the presence or absence of skin hyperpigmentation after foam sclerotherapy | To evaluate the impact of Pycnogenol (FlebonĀ®) 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| The use of Pycnogenol (FlebonĀ®) 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. | 90 days |
| The use of Pycnogenol (FlebonĀ®) triggers a change skin pigmentation. |
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Inclusion Criteria:
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Other | Placebo |
|
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. |
| 90 days |
| The use of Pycnogenol (FlebonĀ®) 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. | 90 days |
| the degree of patient satisfaction with the use of Pycnogenol (FlebonĀ®) 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. | 90 days |
| pycnogenol side effects | report any type of adverse event | 90 days |