E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
A digital myxoid cyst arises from degeneration in the connective tissue of the distal joint of the digit, commonly the finger, and is thought to result from age-related osteoarthritis. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068991 |
E.1.2 | Term | Digital mucous cyst |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Is there a difference in the percentage of patients 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? |
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E.2.2 | Secondary objectives of the trial |
In those treated with polidocanol compared to cryotherapy and also compared to infra-red is there a difference in:
1) Percentage of patients with cyst resolution at 12 and 52 weeks post initial treatment 2) Clinically apparent scarring 3) Procedure pain / discomfort 4) Procedure satisfaction
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Presence of a visible Digital Myxoid Cyst affecting the distal phalynx of toes or fingers.
Ability to give informed consent. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome of this study is to determine if there is a significant difference in the proportion of patients with cyst resolution at 6 weeks post treatment in those treated with polidocanol sclerotherapy compared to cryotherapy and infra-red coagulation. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Subjects will be reviewed as currently standard after 6-8 weeks. All participants will be reviewed again at 12-24 weeks, with scoring of discomfort and satisfaction of those who have undergone a second treatment. All participants will be reviewed finally at about 52 weeks. |
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E.5.2 | Secondary end point(s) |
Patient will be reviewed at 6, 12 and 52 weeks to assess for cyst resolution, failure to respond, or recurrence.
At 6, 12 and 52 weeks the degree of any scarring will be assessed.
At 6 weeks, subjects will asked to assess the degree of pain and discomfort experienced.
At 6 weeks subject’s satisfaction will be assessed.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Subjects will be reviewed as currently standard after 6-8 weeks. All patients will be reviewed again at 12-14 weeks. All patients will be reviewed for a final time at about 52 weeks. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
cryotherapy and infra-red coagulation |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 29 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 30 |