- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00568204
Study of Effectiveness of Mexyn-A (Mexyn-A)
October 16, 2013 updated by: Evangelical Synod Medical Centre
Proof of Concept of MEXYN-A
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
279
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11111
- Evangelical Synod Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Mexyn-A
|
Atomised topical self-chilled pressurised spray
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treating Pruritus
Time Frame: three days
|
three days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
measuring itch-free period after applying the new treatment, effect on sleep disturbance
Time Frame: three days
|
three days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ihab Akhnoukh, Evangelical Synod Medical Centre
- Study Director: Ashraf Khella, Harpur Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Study Completion (Actual)
September 1, 2005
Study Registration Dates
First Submitted
November 30, 2007
First Submitted That Met QC Criteria
November 30, 2007
First Posted (Estimate)
December 5, 2007
Study Record Updates
Last Update Posted (Estimate)
October 17, 2013
Last Update Submitted That Met QC Criteria
October 16, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EvangelicalSynodMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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