EXPLORATORY ASSESSMENT OF THE EFFECTS OF CYCLO 3 ® FORT (Ruscus Extract, Hesperidin Methyl Chalcone, Ascorbic Acid) OR MICRONISED PURIFIED FLAVONOID FRACTION ON VASCULAR PARAMETERS AND BIOMARKERS IN WOMEN SUFFERING FROM CHRONIC VENOUS DISEASE (CEAP C2 OR C3), OVER 8 WEEKS

Chronic Venous Disorder is the most prevalent vascular disease. It is multifactorial pathology that has an important impact on quality of life and represents a significant public health concern, due to its very high frequency in all European and American (north and south) countries.

Venous pathology develops when venous pressure is increased and return of blood is impaired through several mechanisms. Wish induce leg symptoms (tingling, aching, burning, pain, muscle cramps, sensation of swelling, sensations of throbbing or heaviness, itching skin, restless legs, leg tiredness and/or fatigue.

The aims of this research is to study the effects on microcirculatory activity (activity on very small vessels) of CYCLO 3 ® FORT, MPFF (Micronised Purified Flavonoid Fraction) and Placebo after 8 week of treatment by Microscan, and Duplex, two imaging non-invasive technologies will be performed to obtain measurements of microcirculatory parameters in standardized and reproducible conditions for all the participants. In addition, will assess, in blood samples, the inflammatory biomarkers .

Study Overview

• Status: Withdrawn
• Conditions: Venous Disease Classification (CEAP): C2 or C3
• Intervention / Treatment: Drug: CYCLO 3 ® FORT; Drug: placebo MPFF; Drug: MPFF; Drug: placebo CYCLO 3 ® FORT

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Inclusion criteria

   • Non-menopausal women aged from 18 to 50 years
   • Symptomatic Primary chronic disorder C2 or C3 of advanced CEAP
   • Regular menstrual cycle
   • Use an efficient method of contraception
   • Having signed her written informed

2. Non-inclusion criteria 2.1 Related to pathology:

   • Superficial and or deep venous thrombosis
   • Venous insufficiency including history of deep venous thrombosis, post thrombotic syndrome, venous dysplasia, compressive syndrome
   • History of venous strapping or phlebotomy/ surgery of the evaluated leg
   • Sclerosing injection within 6 month before inclusion
   • Oedema from other etiology
   • Paresthesia, cramps of the lower limbs from other origin 2.2 Related to treatment:
   • Hypersensitivity, allergy or intolerance to study drugs
   • Iron storage disorder
   • Intake of venotonic treatment (oral or topic) ,triptan ,diuretics ,calcium blockers, beta blockers, ACE inhibitors, angiotensine II inhibitors, vasodilatators and/or vasoconstrictors within 1 month before inclusion
   • Intake of NSAID,corticosteroids,ergotamine, dihydroergotamine or any ergot alkaloids,vitamin C nutraceutical or phytotherapy products with potential venotonic effect within 2 weeks before inclusion 2.3 Related to the population:
   • History of diabetes
   • BMI≥ 30
   • Grade V and VI on Fitzpatrick classification

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CYCLO 3 ® FORT and placebo MPFF; MPFF = Micronized Purified Flavonoid Fraction	Drug: CYCLO 3 ® FORT; Drug: placebo MPFF
Active Comparator: MPFF and placebo CYCLO 3 ® FORT; MPFF = Micronized Purified Flavonoid Fraction	Drug: MPFF; Drug: placebo CYCLO 3 ® FORT
Placebo Comparator: placebo; MPFF = Micronized Purified Flavonoid Fraction	Drug: placebo MPFF; Drug: placebo CYCLO 3 ® FORT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Capillary diameter	Measure by microscan of capillary diameter, in micrometer on the worst leg (CEAP classification C2 or C3) at Baseline.	From baseline (Day 0) to Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of venoconstriction activity	Measure by Duplex-scan of vein diameter in millimeter on the worst leg (CEAP classification C2 or C3) at Baseline.	From baseline (Day 0) to Day 56

Collaborators and Investigators

• Sponsor: Pierre Fabre Medicament
• Collaborators: Eurotrials Brasil Consultores Cientificos Ltda
• Investigators: Study Director: Zahida Issiakhem Belkaid, MD, Pierre Fabre Medicament

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2016
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): February 20, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: DC0982 GE 2 04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No