The Prevstain Trial

NCT04203043 | Unknown Phase 2 DMC

• 1 other identifier: 08890918.0.0000.0068
• Study Type: interventional
• Target: 338
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (5)

• The use of Pycnogenol (Flebon®) triggers change cutaneous pigmentation;

  90 days

• The use of Pycnogenol (Flebon®) triggers a change skin pigmentation.

  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.

  90 days

• the degree of patient satisfaction with the use of Pycnogenol (Flebon®) regarding the skin aspect of the region submitted to the procedure;

  90 days

• pycnogenol side effects

  90 days

Study Arms (2)

Pycnogenol oral product to prevent Hyperpigmentation

ACTIVE COMPARATOR

Evaluate hyperpigmentation post foam sclerotherapy with placebo versus pycnogenol use

Drug: Pycnogenol Oral Product

Placebo to prevent hyperpigmentation

PLACEBO COMPARATOR

Evaluate hyperpigmentation post foam sclerotherapy with placebo versus pycnogenol use

Other: Placebo

Interventions

Pycnogenol Oral Product DRUG

pycnogenol use to prevent hyper pigmentation after foam sclerotherapy

Pycnogenol oral product to prevent Hyperpigmentation

Placebo OTHER

Placebo

Placebo to prevent hyperpigmentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• no Participants with a history of polyamide or elastane allergy

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of vascular surgery

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 18, 2019
• Study Start: February 28, 2020
• Primary Completion: March 28, 2020
• Study Completion: December 28, 2021
• Last Updated: February 7, 2020

Record last verified: 2020-02