LivRelief Varicose Veins Cream in the Treatment of Varicose Veins

LivRelief Varicose Veins Cream in the Treatment of Chronic Venous Insufficiency of the Lower Limbs: A 6-week Single Arm Pilot Study

Phase IV interventional design where all participants used the test product as per package instructions for 6-weeks. Baseline observations were compared to those collected after 6-weeks of treatment.

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Other: Natural Health Product: LivRelief Varicose Veins Cream

Detailed Description

The use of the marketed natural product, LivRelief Varicose Veins Cream, was observed in 32 patients with lower limb varicose veins. Participants were recruited from the patient population at The Mayer Institute in Hamilton Ontario, Canada. Patients that agreed to participate in the study and met the eligibility criteria were provided with a 6-week supply of the cream to use at home as directed on the product packaging. The following study measures were performed at the clinic prior to the first use of the cream, then again at the clinic after 6 weeks of use: CEAP (Clinical, Etiological, Anatomical, Pathophysiological) classification and VCSS (Venous Clinical Severity score). These are assessments performed by the doctor or nurse to determine the severity of their varicose veins and CVI (chronic venous insufficiency), measurements taken of the circumference of their legs to measure swelling of the legs, photographs of the varicose veins, a quality of life enjoyment and satisfaction questionnaire (QLES-Q-SF) completed by the subjects to describe their satisfaction with various aspects of their life over the last week and documentation of any reactions to the treatment. The cream was applied to their varicose veins twice a day for 6 weeks.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8R 2R3
      • The Mayer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 19 years of age.
• Presence of lower limb varicose veins.

Exclusion Criteria:

• Allergy to witch-hazel or any allergies in the cream.
• Intent to undergo surgical treatment varicose veins within the next six weeks.
• Pregnant or breastfeeding or planning to be pregnant.
• Any Dementia or Major Cognitive dysfunction that would preclude the individual's ability to provide informed consent or complete the Case Report Form.
• Any unstable medical condition (including but not limited to cardiovascular, cardiac/hypertension disease, moderate to severe kidney disease, and moderate to severe liver disease)
• Any medical condition that would preclude the participant's or a caregiver's ability to administer the product on a daily basis for the time period required to complete the study.
• An active ulcer at the site of product application (as evaluated during CEAP screening).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LivRelief Varicose Veins Cream; Intervention: All subjects were provided with an adequate supply of the Natural Health Product LivRelief Varicose Veins cream for 6 weeks of at home use.	Other: Natural Health Product: LivRelief Varicose Veins Cream; This product is intended to improve circulation and blood flow to minimize the appearance of varicose veins.; Other Names: Natural Product Number (NPN) 80029349

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment feasibility	Recruitment of at least 70% of all eligible participants	study duration:~4 weeks
Data Collection	Collection of at least 70% of scheduled data	study duration: ~6 to 12 weeks

Collaborators and Investigators

• Sponsor: Delivra, Inc.
• Investigators: Principal Investigator: Perry V Mayer, MD, The Mayer Institute

Publications and helpful links

General Publications

• Dwyer HC, Baranowski DC, Mayer PV, Gabriele S. LivRelief varicose veins cream in the treatment of chronic venous insufficiency of the lower limbs: A 6-week single arm pilot study. PLoS One. 2018 Dec 31;13(12):e0208954. doi: 10.1371/journal.pone.0208954. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): August 28, 2017
• Study Completion (Actual): August 28, 2017

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: Pro00020990

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