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

Ganglion Cysts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02154789
• Other study ID #: 2013-005338-39
• Status: Terminated
• Phase: Phase 4
• Start date: July 27, 2015
• Est. completion date: October 1, 2015

Study information

• Verified date: May 2024
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 1, 2015
• Est. primary completion date: October 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cysts
• Ganglion Cysts

Intervention

Drug:
• polidocanol

Procedure:
• infra-red coagulation

• cryotherapy

Locations

Country	Name	City	State
United Kingdom	Queen Margaret Hospital, Whitefield Road	Dunfermline	Fife
United Kingdom	Department of Dermatology, Royal Infirmary	Edinburgh	Midlothian

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	Foundation for Skin Research, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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