PruritusMexyn-ANCT00568204
Study of Effectiveness of Mexyn-A
A study testing Mexyn-A in people with Pruritus, run by Evangelical Synod Medical Centre at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pruritus
- What is being tested?
- Mexyn-A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2002to Sep 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pruritus
- Being tested
- Mexyn-A
- Keywords
- pruritus, itching, mexyn-a, clearitch, magicool-plus
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mexyn-ADevice
Also called Clearitch, Itcharret, itchclear, Magicool-Plus
Atomised topical self-chilled pressurised spray
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Mexyn-A Receives: Device: Mexyn-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treating Pruritus
Measured: three days
Secondary outcomes (1)
measuring itch-free period after applying the new treatment, effect on sleep disturbance
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startMar 2002
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelical Synod Medical Centre
- Sponsor type
- University, hospital or other
- Investigators
- Ihab Akhnoukh, Principal investigator, Evangelical Synod Medical CentreAshraf Khella, Study director, Harpur Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568204
- Sponsor's protocol ID
- EvangelicalSynodMC
- Acronym
- Mexyn-A
- Status last verified
- Oct 2013
- First submitted
- 30 Nov 2007
- Last updated
- 17 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept of MEXYN-A
- ClinicalTrials.gov ID
- NCT00568204
- Acronym / sponsor ID
- Mexyn-A / EvangelicalSynodMC
- Conditions
- Pruritus
- Keywords
- pruritus, itching, mexyn-a, clearitch, magicool-plus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Evangelical Synod Medical CentreUniversity, hospital or other
- Study start
- Mar 2002
- Study completion
- Sep 2005 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Mexyn-AMexyn-A |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mexyn-AAlso: Clearitch, Itcharret, itchclear, Magicool-PlusAtomised topical self-chilled pressurised spray | Device | 1 |
Primary outcome
Treating Pruritus
Time frame: three days
1 secondary outcome
measuring itch-free period after applying the new treatment, effect on sleep disturbance
Time frame: three days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ihab Akhnoukh principal investigator
Evangelical Synod Medical Centre
Ashraf Khella study director
Harpur Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mexyn-A in people with Pruritus, run by Evangelical Synod Medical Centre at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treating Pruritus (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2013.