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

Phase 4

Terminated

• Conditions: Ganglion Cysts
• Interventions: Drug: polidocanol; Procedure: infra-red coagulation; Procedure: cryotherapy

• Registration Number: NCT02154789
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-03
• Study Start: 2015-07-27
• Primary Completion: 2015-10-01
• Study Completion: 2015-10-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
polidocanol	polidocanol	-
infra-red coagulation	infra-red coagulation	-
cryotherapy	cryotherapy	-

Primary Outcome Measures

Name	Time	Method
cyst resolution at 6 weeks	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?

Secondary Outcome Measures

Name	Time	Method
cyst resolution at 12 and 52 weeks	1 year	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
pain scores on a visual analogue scale	1 year	In 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 scale	1 year	In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in procedure satisfaction
difference in scarring	1 year	In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in clinically apparent scarring

Trial Locations

Locations (2)

Queen Margaret Hospital, Whitefield Road; 🇬🇧 Dunfermline, Fife, United Kingdom

Department of Dermatology, Royal Infirmary; 🇬🇧 Edinburgh, Midlothian, United Kingdom