An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst
1 other identifier
interventional
10
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2015
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2014
CompletedFirst Posted
Study publicly available on registry
June 3, 2014
CompletedStudy Start
First participant enrolled
July 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMay 30, 2024
May 1, 2024
2 months
May 15, 2014
May 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
cyst resolution at 12 and 52 weeks
1 year
difference in scarring
1 year
pain scores on a visual analogue scale
1 year
procedure satisfaction on a visual analogue scale
1 year
Study Arms (3)
polidocanol
EXPERIMENTALcryotherapy
ACTIVE COMPARATORinfra-red coagulation
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- NHS Lothiancollaborator
- Foundation for Skin Researchcollaborator
Study Sites (2)
Queen Margaret Hospital, Whitefield Road
Dunfermline, Fife, KY12, United Kingdom
Department of Dermatology, Royal Infirmary
Edinburgh, Midlothian, EH3 9HA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen A Holme, MBChB
University of Edinburgh
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2014
First Posted
June 3, 2014
Study Start
July 27, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
May 30, 2024
Record last verified: 2024-05