Back to resultsStudy of Effectiveness of Mexyn-A (Mexyn-A)
Primary Purpose
Pruritus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mexyn-A
Sponsored by
About this trial
This is an interventional treatment trial for Pruritus focused on measuring pruritus, itching, mexyn-a, clearitch, magicool-plus
Eligibility Criteria
Inclusion Criteria:
- Patients suffering from severe itching due to : Atopic Dermatitis, contact dermatitis, psoriasis, urticaria, xerosis, prickly heat, genital pruritus, chicken pox, aquagenic pruritus, lichen planus, poison ivey, insect bites.
- Past experience with the use of at least one conventional medication for pruritus or conventional medication for the same disorder patients suffered.
Exclusion Criteria:
- Patients who have taken any anti-pruritic drug during the month prior to participation.
- Patients who have taken drugs for any reason for 2 days prior to participating in the study.
Sites / Locations
- Evangelical Synod Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Mexyn-A
Outcomes
Primary Outcome Measures
Treating Pruritus
Secondary Outcome Measures
measuring itch-free period after applying the new treatment, effect on sleep disturbance
Full Information
NCT ID
NCT00568204
First Posted
November 30, 2007
Last Updated
October 16, 2013
Sponsor
Evangelical Synod Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT00568204
Brief Title
Study of Effectiveness of Mexyn-A
Acronym
Mexyn-A
Official Title
Proof of Concept of MEXYN-A
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Evangelical Synod Medical Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Atomised Methoxymethane-in-Aqua (MEXYN-A) a new topical self-chilled, non-steroidal, non-flammable, pressurised spray which embodies in one simultaneous application, most of the currently recognised and effective chemical, mechanical and thermal anti-pruritic therapies and hydrotherapy.
Detailed Description
The primary clinical endpoint was to establish MEXYN-A efficacy and safety in abolishing or reducing pruritus related to cutaneous diseases, insect bites and poison ivy, within few seconds of the application. The secondary endpoint was to measure the itch free period as a result of the new intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
Keywords
pruritus, itching, mexyn-a, clearitch, magicool-plus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
279 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Mexyn-A
Intervention Type
Device
Intervention Name(s)
Mexyn-A
Other Intervention Name(s)
Clearitch, Itcharret, itchclear, Magicool-Plus
Intervention Description
Atomised topical self-chilled pressurised spray
Primary Outcome Measure Information:
Title
Treating Pruritus
Time Frame
three days
Secondary Outcome Measure Information:
Title
measuring itch-free period after applying the new treatment, effect on sleep disturbance
Time Frame
three days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients suffering from severe itching due to : Atopic Dermatitis, contact dermatitis, psoriasis, urticaria, xerosis, prickly heat, genital pruritus, chicken pox, aquagenic pruritus, lichen planus, poison ivey, insect bites.
Past experience with the use of at least one conventional medication for pruritus or conventional medication for the same disorder patients suffered.
Exclusion Criteria:
Patients who have taken any anti-pruritic drug during the month prior to participation.
Patients who have taken drugs for any reason for 2 days prior to participating in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ihab Akhnoukh
Organizational Affiliation
Evangelical Synod Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashraf Khella
Organizational Affiliation
Harpur Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Evangelical Synod Medical Centre
City
Cairo
ZIP/Postal Code
11111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Study of Effectiveness of Mexyn-A
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