The Effect of Cooling on Sclerotherapy Efficacy

The primary objective of this study is to evaluate the efficacy of sclerotherapy with forced-air cooling during treatment.

Study Overview

• Status: Unknown
• Conditions: Leg Veins
• Intervention / Treatment: Drug: air cooling

Detailed Description

Study Objective: The primary objective of this study is to evaluate the efficacy of sclerotherapy with forced-air cooling during treatment.

Study Design: This will be an investigator-initiated, evaluator-blinded, randomized-controlled, prospective, single-center clinical trial.

Study Population: 20 evaluable subjects with bilateral lower extremity reticular and telangiectatic veins, who meet all study inclusion/exclusion criteria will be considered for entry into the study.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Recruiting
      • West Dermatology Research Center/Cosmetic Laser Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The subject is a male or female of skin type I to IV between 25 and 75 years of age.
• The subject has mild venous disease (CEAP Class C1) (CLINICAL SEVERITY ETIOLOGY OR CAUSE ANATOMY AND PATHOPHYSIOLOGY)
• Reticular veins and telangiectasias on symmetrical bilateral lower extremities.
• The subject is willing to follow study instructions and complete all required visits, as well as has agreed to and signed the written informed consent form.
• The subject is healthy as judged by medical history and investigator's assessment of current health.
• The subject is not suffering from any skin condition (infection, dermatosis, etc.) that in the opinion of the investigator may place them at risk.
• Females of childbearing potential must use one of the following types of birth control for the duration of the study. These include: Oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g. condoms with spermicide), abstinence, or partner vasectomy, with a documented second acceptable method of birth control should they become sexually active. All birth control measures must be in consistent use for at least 30 days prior to the start of study.

Exclusion Criteria:

• A subject requires greater than 10 mL total of glycerin, including a maximum of 6 mL of polidocanol for foam sclerotherapy, for either lower extremity during a single leg treatment.
• Asymmetric amount, distribution, and/or severity of reticular veins and/or telangiectasias between lower extremities
• The subject has a CEAP Class of C2 or greater, as evidenced by clinically apparent varicosities, venous stasis, stasis dermatitis, lipodermatosclerosis, and/or venous ulceration (or history of lower leg ulcerations).
• The subject has history of or current great saphenous vein (GSV), saphenofemoral junction (SFJ), or saphenopopliteal junction (SPJ) incompetency based on prior Doppler and/or duplex evaluation or has physical exam findings suspicious for it.
• The subject has a history of deep vein thrombosis, thrombophlebitis, thromboembolic disease, and/or underlying hypercoagulable medical condition (e.g. hemophilia, Factor V deficiency).
• The subject has a history of uncontrolled or severe asthma, or asthma requiring hospitalization or intubation.
• The subject has a history of allergic reactions to sclerosing agent.
• The subject has a history of allergic reaction or sensitivity to lidocaine or epinephrine.

• Any of the following medications, procedures or treatments to the purposed treatment area/s

  1. Within 6 months prior to screening visit (i.) The subject has undergone sclerotherapy
  2. Within 3 months prior to screening visit (I.) NO OTHER COSMETIC OR SURGICAL TREATMENTS TO THE PURPOSED TREATMENT AREA/S
• The subject is non-ambulatory or poorly ambulatory.
• The subject has a history of neurological conditions.
• The subject is pregnant, lactating, or in child bearing age (and sexually active) and not using an approved contraceptive measure.
• The subject is taking disulfiram, tamoxifen, or oral hormone therapy (not including hormonal birth control).
• The subject has a history of noncompliance with clinical protocols.
• The subject has participated in any other clinical trial that involves an investigational medication or device within the last 30 days.
• Planning to have any treatments or procedures to bilateral lower extremities for the duration of the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: treatment with forced-air cooling; comparing treatment with and without forced-air cooling in a comparative lower extremity model	Drug: air cooling; intervention is adding air-cooling to treatment
NO_INTERVENTION: treatment without forced-air cooling; comparing treatment without forced-air cooling in a comparative lower extremity model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to evaluate the effect of forced-air cooling on sclerotherapy	to evaluate the effect of forced-air cooling on sclerotherapy of lower extremity telangiectasias and reticular veins. This will be assessed by comparing treatment with and without forced-air cooling in a comparative lower extremity model.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
is to compare reticular vein and telangiectasia diameter measurements	to compare reticular vein and telangiectasia diameter measurements via a polarized LED wireless digital microscope before treatment and during cooling in the forced-air cooling group.	1 year

Collaborators and Investigators

• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2020
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (ACTUAL): December 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ScleroTT2019-01

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes