The Prevstain Trial

• Status: Not yet recruiting
• Trial end date: 2021-12-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Pycnogenols

Criteria

Inclusion Criteria:

• 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.

• Exclusion Criteria:

• 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.

• 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