An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst
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| ClinicalTrials.gov Identifier: NCT02154789 |
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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
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ganglion Cysts | Drug: polidocanol Procedure: infra-red coagulation Procedure: cryotherapy | Phase 4 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: polidocanol |
Drug: polidocanol |
| Active Comparator: cryotherapy |
Procedure: cryotherapy |
| Active Comparator: infra-red coagulation |
Procedure: infra-red coagulation |
- 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?
- 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
- 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
- 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
- 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 |
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
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
| Contact: S A Holme, MBChB | 01315362410 |
| United Kingdom | |
| Queen Margaret Hospital, Whitefield Road | |
| Dunfermline, Fife, United Kingdom, KY12 | |
| Contact: M Mowbray, MBChB 01383 623623 | |
| Principal Investigator: M MOwbray, MBChB | |
| Department of Dermatology, Royal Infirmary | |
| 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 | |
| Principal Investigator: | Stephen A Holme, MBChB | University of Edinburgh |
| Responsible Party: | University of Edinburgh |
| ClinicalTrials.gov Identifier: | NCT02154789 |
| 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 |
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Ganglion Cysts Cysts Neoplasms Mucinoses Connective Tissue Diseases |
Pathological Conditions, Anatomical Polidocanol Sclerosing Solutions Pharmaceutical Solutions |

