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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02154789
Enrollment
10
Registered
2014-06-03
Start date
2015-07-27
Completion date
2015-10-01
Last updated
2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ganglion Cysts

Brief 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. 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.

Interventions

PROCEDUREinfra-red coagulation
PROCEDUREcryotherapy

Sponsors

NHS Lothian
CollaboratorOTHER_GOV
Foundation for Skin Research
CollaboratorUNKNOWN
University of Edinburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
cyst resolution at 6 weeks6 weeksIs 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?

Secondary

MeasureTime frameDescription
cyst resolution at 12 and 52 weeks1 yearIn 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
difference in scarring1 yearIn those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in clinically apparent scarring
pain scores on a visual analogue scale1 yearIn those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in procedure pain/discomfort
procedure satisfaction on a visual analogue scale1 yearIn those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in procedure satisfaction

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026