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

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ClinicalTrials.gov Identifier: NCT02154789
Recruitment Status : Unknown
Verified May 2014 by University of Edinburgh.
Recruitment status was:  Not yet recruiting
First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Collaborators:
NHS Lothian
Foundation for Skin Research
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ganglion Cysts Drug: polidocanol Procedure: infra-red coagulation Procedure: cryotherapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cysts
Study Start Date : June 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Polidocanol

Arm Intervention/treatment
Experimental: polidocanol Drug: polidocanol
Active Comparator: cryotherapy Procedure: cryotherapy
Active Comparator: infra-red coagulation Procedure: infra-red coagulation



Primary Outcome Measures :
  1. cyst resolution at 6 weeks [ Time Frame: 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 :
  1. cyst resolution at 12 and 52 weeks [ Time Frame: 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

  2. difference in scarring [ Time Frame: 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

  3. pain scores on a visual analogue scale [ Time Frame: 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

  4. procedure satisfaction on a visual analogue scale [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154789


Contacts
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Contact: S A Holme, MBChB 01315362410

Locations
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United Kingdom
Queen Margaret Hospital, Whitefield Road Not yet recruiting
Dunfermline, Fife, United Kingdom, KY12
Contact: M Mowbray, MBChB    01383 623623      
Principal Investigator: M MOwbray, MBChB         
Department of Dermatology, Royal Infirmary Not yet recruiting
Edinburgh, Midlothian, United Kingdom, EH3 9HA
Contact: S A Holme, MBChB    01315362410      
Principal Investigator: S A Holme, MBChB         
Sub-Investigator: C Sinclair, MD         
Sub-Investigator: E T Ooi, MD         
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Foundation for Skin Research
Investigators
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Principal Investigator: Stephen A Holme, MBChB University of Edinburgh

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02154789     History of Changes
Other Study ID Numbers: 2013-005338-39
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
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Cysts
Ganglion Cysts
Synovial Cyst
Neoplasms
Pathological Conditions, Anatomical
Mucinoses
Connective Tissue Diseases
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions