Leg VeinsPhase 4NCT04690803
The Effect of Cooling on Sclerotherapy Efficacy
A Phase 4 study testing air cooling in people with Leg Veins, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy of sclerotherapy with forced-air cooling during treatment. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Leg Veins
- What is being tested?
- air cooling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 1 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
West Dermatology Research Center/Cosmetic Laser Dermatology
San Diego, California, 92121
Leslie Aguilar, BA, 858-657-1004, laguilar@clderm.com
Sherif Mikhail, MD, 8586571004, SMikhail@clderm.com
About this study
The primary objective of this study is to evaluate the efficacy of sclerotherapy with forced-air cooling during treatment.
Read the 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.
- Conditions
- Leg Veins
- Being tested
- air cooling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
air coolingDrug
intervention is adding air-cooling to treatment
| Study group | Role | What they receive |
|---|---|---|
| treatment with forced-air cooling | Active comparator | comparing treatment with and without forced-air cooling in a comparative lower extremity model Receives: Drug: air cooling |
| treatment without forced-air cooling | No intervention | comparing treatment without forced-air cooling in a comparative lower extremity model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start6 Jan 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- sclerotherapy with forced-air cooling during treatment.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690803
- Sponsor's protocol ID
- ScleroTT2019-01
- Status last verified
- Dec 2020
- First submitted
- 28 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cooling on Sclerotherapy Efficacy
- ClinicalTrials.gov ID
- NCT04690803
- Acronym / sponsor ID
- ScleroTT2019-01
- Conditions
- Leg Veins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy of sclerotherapy with forced-air cooling during treatment.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- sclerotherapy with forced-air cooling during treatment.
| Arm | Type | Receives |
|---|---|---|
| treatment with forced-air cooling | Active comparator | Drug: air coolingcomparing treatment with and without forced-air cooling in a comparative lower extremity model |
| treatment without forced-air cooling | No intervention | –comparing treatment without forced-air cooling in a comparative lower extremity model |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| air coolingintervention is adding air-cooling to treatment | Drug | treatment with forced-air cooling |
Primary outcome
to evaluate the effect of forced-air cooling on sclerotherapy
Time frame: 1 year
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 secondary outcome
is to compare reticular vein and telangiectasia diameter measurements
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing air cooling in people with Leg Veins, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leslie Aguilar, BA (18586571004, laguilar@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the effect of forced-air cooling on sclerotherapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.