Microcautery for Leg VeinsNCT04072172
Microcautery for the Treatment of Spider Leg Veins
A study testing Mole Freckle Pen in people with Microcautery for Leg Veins, run by Assiut University.
Trial summary
To Evaluate the role of micro-cauterization use in the treatment and disappearance of spider leg veins. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microcautery for Leg Veins
- What is being tested?
- Mole Freckle Pen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to Oct 2020
- Phase
- Interventional
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- were patients with spider veins of less than 2.0 mm in diameter.
Who cannot join
- were patients with diabetes, anticoagulation therapy and/or patients with a known history of keloids
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Microcautery Evaluation for Treatment of Leg Spiders
To Evaluate the role of micro-cauterization use in the treatment and disappearance of spider leg veins.
Read the detailed description
Spider veins on the lower limbs are very common and have been reported to be presented in 41% of women over 50 years old. Sclerotherapy as a traditional treatment for spider veins has a low cost, though it may have adverse sequelae. Lasers have shown fewer but still substantial complications as well.1 Spider veins are small superficial veins that widen and become visible, often on the legs and most cutaneous spider veins are abnormalities of the horizontal vascular skin plexus or capillary loops.2 Spider leg veins are composed of a feeder vessel and ectatic venous sprouts in the reticular dermis. Their depth is between 180 µm and 1 mm in the skin.3 Spider veins may have a diameter that reaches several millimetres and can be blue, purple or red and may appear in the form of thin lines, webs or branches.4 There is a scarce available data from literature about the role of micro-cauterization in the treatment of spider veins. The micro-cauterization is an alternative in management of spider veins that delivered via Mole Freckle Pen German Technology.4 Cautery is a safe and effective tool for the treatment of superficial and small skin lesions. It is simple, cheap, and requires minimal training and the results are usually satisfactory Technology Specifications with insulated micro steel needle use current: 5V / 1A of 5-speed free adjustment.5 The current study aims to evaluate the role for micro-cauterization in the treatment and disappearance of spider leg veins.
- Conditions
- Microcautery for Leg Veins
- Being tested
- Mole Freckle Pen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mole Freckle PenDevice
Insulated micro steel needle use current: 5V / 1A of 5-speed free adjustment.5
| Study group | Role | What they receive |
|---|---|---|
| Female with leg spider veins | Experimental | Females at the age of 20 to 45 not known diabetics or hypertensive complaining of leg spider veins. Receives: Device: Mole Freckle Pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term results after 3 weeks.
Compare between the shape of spider leg veins pre and post the cauterization session depending on standard Oriented photos taken pre and post.
Measured: 3 weeks
Secondary outcomes (1)
Long term results after 3 months.
Study, monitor and evaluate the long term results of the cautery session after 3 months and if there is any reappearance of the spider veins with a standard Oriented photos taken.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microcautery for Leg VeinsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa M. Selim, Assiut University
- Investigators
- Doaa M. Selim, Resident, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072172
- Sponsor's protocol ID
- Micro-cautery for leg veins
- Status last verified
- Sep 2019
- First submitted
- 25 Aug 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcautery Evaluation for Treatment of Leg Spiders
- ClinicalTrials.gov ID
- NCT04072172
- Acronym / sponsor ID
- Micro-cautery for leg veins
- Conditions
- Microcautery for Leg Veins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 28 Aug 2019 (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.
To Evaluate the role of micro-cauterization use in the treatment and disappearance of spider leg veins.
Detailed description
Spider veins on the lower limbs are very common and have been reported to be presented in 41% of women over 50 years old. Sclerotherapy as a traditional treatment for spider veins has a low cost, though it may have adverse sequelae. Lasers have shown fewer but still substantial complications as well.1 Spider veins are small superficial veins that widen and become visible, often on the legs and most cutaneous spider veins are abnormalities of the horizontal vascular skin plexus or capillary loops.2 Spider leg veins are composed of a feeder vessel and ectatic venous sprouts in the reticular dermis. Their depth is between 180 µm and 1 mm in the skin.3 Spider veins may have a diameter that reaches several millimetres and can be blue, purple or red and may appear in the form of thin lines, webs or branches.4 There is a scarce available data from literature about the role of micro-cauterization in the treatment of spider veins. The micro-cauterization is an alternative in management of spider veins that delivered via Mole Freckle Pen German Technology.4 Cautery is a safe and effective tool for the treatment of superficial and small skin lesions. It is simple, cheap, and requires minimal training and the results are usually satisfactory Technology Specifications with insulated micro steel needle use current: 5V / 1A of 5-speed free adjustment.5 The current study aims to evaluate the role for micro-cauterization in the treatment and disappearance of spider leg veins.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female with leg spider veins | Experimental | Device: Mole Freckle PenFemales at the age of 20 to 45 not known diabetics or hypertensive complaining of leg spider veins. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- were patients with spider veins of less than 2.0 mm in diameter.
Key exclusion criteria (1 listed)
- were patients with diabetes, anticoagulation therapy and/or patients with a known history of keloids
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 |
|---|---|---|
| Mole Freckle PenInsulated micro steel needle use current: 5V / 1A of 5-speed free adjustment.5 | Device | Female with leg spider veins |
Primary outcome
Short term results after 3 weeks.
Time frame: 3 weeks
Compare between the shape of spider leg veins pre and post the cauterization session depending on standard Oriented photos taken pre and post.
1 secondary outcome
Long term results after 3 months.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
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.
Doaa M. Selim, Resident principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Mole Freckle Pen in people with Microcautery for Leg Veins, run by Assiut University.
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 1 inclusion and 1 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 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Doaa M. Selim, Resident (00201009882011, Doaamselim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term results after 3 weeks. (time frame: 3 weeks). 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 11 Sep 2019.