search
Back to results

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

Primary Purpose

Ganglion Cysts

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
polidocanol
infra-red coagulation
cryotherapy
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ganglion Cysts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Queen Margaret Hospital, Whitefield Road
  • Department of Dermatology, Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

polidocanol

cryotherapy

infra-red coagulation

Arm Description

Outcomes

Primary Outcome Measures

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?

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
May 15, 2014
Last Updated
May 30, 2014
Sponsor
University of Edinburgh
Collaborators
NHS Lothian, Foundation for Skin Research
search

1. Study Identification

Unique Protocol Identification Number
NCT02154789
Brief Title
An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst
Official Title
An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cysts
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian, Foundation for Skin Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ganglion Cysts

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
polidocanol
Arm Type
Experimental
Arm Title
cryotherapy
Arm Type
Active Comparator
Arm Title
infra-red coagulation
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
polidocanol
Intervention Type
Procedure
Intervention Name(s)
infra-red coagulation
Intervention Type
Procedure
Intervention Name(s)
cryotherapy
Primary Outcome Measure Information:
Title
cyst resolution at 6 weeks
Description
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?
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
cyst resolution at 12 and 52 weeks
Description
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
Time Frame
1 year
Title
difference in scarring
Description
In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in clinically apparent scarring
Time Frame
1 year
Title
pain scores on a visual analogue scale
Description
In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in procedure pain/discomfort
Time Frame
1 year
Title
procedure satisfaction on a visual analogue scale
Description
In those participants treated with polidocanol compared to cryotherapy and also compared to infra-red coagulation is there a difference in procedure satisfaction
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
S A Holme, MBChB
Phone
01315362410
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen A Holme, MBChB
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Margaret Hospital, Whitefield Road
City
Dunfermline
State/Province
Fife
ZIP/Postal Code
KY12
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Mowbray, MBChB
Phone
01383 623623
First Name & Middle Initial & Last Name & Degree
M MOwbray, MBChB
Facility Name
Department of Dermatology, Royal Infirmary
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH3 9HA
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S A Holme, MBChB
Phone
01315362410
First Name & Middle Initial & Last Name & Degree
S A Holme, MBChB
First Name & Middle Initial & Last Name & Degree
C Sinclair, MD
First Name & Middle Initial & Last Name & Degree
E T Ooi, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs