Ganglion CystsPhase 4NCT02154789
An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst
A Phase 4 study testing polidocanol, infra-red coagulation and cryotherapy in people with Ganglion Cysts, run by University of Edinburgh at 2 sites in United Kingdom.
Trial summary
Digital myxoid cysts arise from degeneration in the connective tissue of the digit joint, usually the last joint of the finger or toe, often due to underlying joint arthritis. They may connect with the joint. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ganglion Cysts
- What is being tested?
- polidocanol, infra-red coagulation and cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 27 Jul 2015to 1 Oct 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients referred to dermatology in NHS Lothian or NHS Fife who have a visible Digital Myxoid Cyst affective the dital phalynx of the toes or fingers.
- The patient must have the ability to give informed consent
Who cannot join
- History of sensitivity to polidocanol or other sclerosants
- Age less than 18
- Inability to give informed consent
- Inability to report side effects experienced
- Cyst not clearly visible
- Cyst not fluid-filled
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Queen Margaret Hospital, Whitefield Road
Dunfermline, Fife, KY12
Department of Dermatology, Royal Infirmary
Edinburgh, Midlothian, EH3 9HA
About this study
Official title: An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cysts
Digital myxoid cysts arise from degeneration in the connective tissue of the digit joint, usually the last joint of the finger or toe, often due to underlying joint arthritis. They may connect with the joint. Pressure from the cyst can result in deformity of the digit's nail and trauma to the cyst results in leakage of the fluid, representing a potential source of entry for infection. Cysts can be tender and interfere with the digit's function. A variety of treatments are available, from simple extrusion which is rarely successful, to more destructive cryotherapy, infra-red coagulation and formal excision under local anaesthetic. These latter three approaches can result in considerable scarring. Sclerosant injection of polidocanol in one small non-randomised trial has been reported to be a well tolerated efficacious treatment with minimal scarring and long-term resolution. Following a pilot study, the investigators aim to trial this treatment to assess efficacy in a larger population.
- Conditions
- Ganglion Cysts
- Being tested
- polidocanol, infra-red coagulation, cryotherapy
- Medical subject headings
- Ganglion Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polidocanolDrug
infra-red coagulationProcedure or surgery
cryotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| polidocanol | Experimental | Not described Receives: Drug: polidocanol |
| cryotherapy | Active comparator | Not described Receives: Procedure: cryotherapy |
| infra-red coagulation | Active comparator | Not described Receives: Procedure: infra-red coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cyst resolution at 6 weeks
Is there a difference in the percentage of participants with cyst resolution at 6 weeks post treatment in those treated with polidocanol compared to those treated with the current conventional treatments of cryotherapy and infra-red coagulation?
Measured: 6 weeks
Secondary outcomes (4)
cyst resolution at 12 and 52 weeks
In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in the percentage of participants with cyst resolution at 12 and 52 weeks post initial treatment
Measured: 1 year
difference in scarring
In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in clinically apparent scarring
Measured: 1 year
pain scores on a visual analogue scale
In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in procedure pain/discomfort
Measured: 1 year
procedure satisfaction on a visual analogue scale
In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in procedure satisfaction
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 posted3 Jun 2014 (estimated)
- Study start27 Jul 2015
- Primary completion1 Oct 2015
- Study completion1 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ganglion CystsStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, Foundation for Skin Research
- Responsible party
- Sponsor
- Investigators
- Stephen A Holme, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154789
- Sponsor's protocol ID
- 2013-005338-39
- Status last verified
- May 2024
- First submitted
- 15 May 2014
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cysts
- ClinicalTrials.gov ID
- NCT02154789
- Acronym / sponsor ID
- 2013-005338-39
- Conditions
- Ganglion Cysts
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, Foundation for Skin Research
- Study start
- 27 Jul 2015 (actual)
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Oct 2015 (actual)
- First posted
- 3 Jun 2014 (estimated)
- 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.
Digital myxoid cysts arise from degeneration in the connective tissue of the digit joint, usually the last joint of the finger or toe, often due to underlying joint arthritis. They may connect with the joint. Pressure from the cyst can result in deformity of the digit's nail and trauma to the cyst results in leakage of the fluid, representing a potential source of entry for infection. Cysts can be tender and interfere with the digit's function. A variety of treatments are available, from simple extrusion which is rarely successful, to more destructive cryotherapy, infra-red coagulation and formal excision under local anaesthetic. These latter three approaches can result in considerable scarring. Sclerosant injection of polidocanol in one small non-randomised trial has been reported to be a well tolerated efficacious treatment with minimal scarring and long-term resolution. Following a pilot study, the investigators aim to trial this treatment to assess efficacy in a larger population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| polidocanol | Experimental | Drug: polidocanol |
| cryotherapy | Active comparator | Procedure: cryotherapy |
| infra-red coagulation | Active comparator | Procedure: infra-red coagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients referred to dermatology in NHS Lothian or NHS Fife who have a visible Digital Myxoid Cyst affective the dital phalynx of the toes or fingers.
- The patient must have the ability to give informed consent
Key exclusion criteria (6 listed)
- History of sensitivity to polidocanol or other sclerosants
- Age less than 18
- Inability to give informed consent
- Inability to report side effects experienced
- Cyst not clearly visible
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 |
|---|---|---|
| polidocanol | Drug | polidocanol |
| infra-red coagulation | Procedure or surgery | infra-red coagulation |
| cryotherapy | Procedure or surgery | cryotherapy |
Primary outcome
cyst resolution at 6 weeks
Time frame: 6 weeks
Is there a difference in the percentage of participants with cyst resolution at 6 weeks post treatment in those treated with polidocanol compared to those treated with the current conventional treatments of cryotherapy and infra-red coagulation?
4 secondary outcomes
cyst resolution at 12 and 52 weeks
Time frame: 1 year
difference in scarring
Time frame: 1 year
pain scores on a visual analogue scale
Time frame: 1 year
procedure satisfaction on a visual analogue scale
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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.
Stephen A Holme, MBChB principal investigator
University of Edinburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing polidocanol, infra-red coagulation and cryotherapy in people with Ganglion Cysts, run by University of Edinburgh at 2 sites in United Kingdom.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cyst resolution at 6 weeks (time frame: 6 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 30 May 2024.