The Effect of Cooling on Sclerotherapy Efficacy

NCT04690803 | Unknown Phase 4 FDA Drug

• 1 other identifier: ScleroTT2019-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Leg Veins

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• is to compare reticular vein and telangiectasia diameter measurements

  1 year

Study Arms (2)

treatment with forced-air cooling

ACTIVE COMPARATOR

comparing treatment with and without forced-air cooling in a comparative lower extremity model

Drug: air cooling

treatment without forced-air cooling

NO INTERVENTION

comparing treatment without forced-air cooling in a comparative lower extremity model

Interventions

air cooling DRUG

intervention is adding air-cooling to treatment

treatment with forced-air cooling

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Within 6 months prior to screening visit (i.) The subject has undergone sclerotherapy
• 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).

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead

Study Sites (1)

West Dermatology Research Center/Cosmetic Laser Dermatology

San Diego, California, 92121, United States

RECRUITING

Central Study Contacts

Leslie Aguilar, BA

CONTACT

18586571004; laguilar@clderm.com

Sherif Mikhail

CONTACT

8586571004; SMikhail@clderm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: evaluator-blinded
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: sclerotherapy with forced-air cooling during treatment.

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 31, 2020
• Study Start: January 6, 2020
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)