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

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 Overview

• Status: Terminated
• Conditions: Ganglion Cysts
• Intervention / Treatment: Drug: polidocanol; Procedure: cryotherapy; Procedure: infra-red coagulation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Fife
    • Dunfermline, Fife, United Kingdom, KY12
      • Queen Margaret Hospital, Whitefield Road
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH3 9HA
      • Department of Dermatology, Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian; Foundation for Skin Research
• Investigators: Principal Investigator: Stephen A Holme, MBChB, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimated): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Connective Tissue Diseases; Pathological Conditions, Anatomical; Mucinoses; Ganglion Cysts; Cysts; Pharmaceutical Solutions; Sclerosing Solutions; Polidocanol
• Other Study ID Numbers: 2013-005338-39