An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst

Study Overview
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Brief Summary
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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.

Official Title
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An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cysts

Conditions
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Ganglion Cysts

Intervention / Treatment
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* Drug: polidocanol
* Procedure: infra-red coagulation
* Procedure: cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: polidocanol<br> | Drug: polidocanol<br> <br> |
| Active Comparator: cryotherapy<br> | Procedure: cryotherapy<br> <br> |
| Active Comparator: infra-red coagulation<br> | Procedure: infra-red coagulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 1 year |