Study of Effectiveness of Mexyn-A

This study has been completed.
Sponsor:
Information provided by:
Evangelical Synod Medical Centre
ClinicalTrials.gov Identifier:
NCT00568204
First received: November 30, 2007
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Pruritus
Device: Mexyn-A

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Proof of Concept of MEXYN-A

Resource links provided by NLM:


Further study details as provided by Evangelical Synod Medical Centre:

Primary Outcome Measures:
  • Treating Pruritus [ Time Frame: three days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • measuring itch-free period after applying the new treatment, effect on sleep disturbance [ Time Frame: three days ] [ Designated as safety issue: Yes ]

Enrollment: 279
Study Start Date: March 2002
Study Completion Date: September 2005
Arms Assigned Interventions
Experimental: 1
Mexyn-A
Device: Mexyn-A
Atomised topical self-chilled pressurised spray
Other Name: Clearitch, Itcharret, itchclear, Magicool-Plus

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.

  Eligibility

Ages Eligible for Study:   5 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568204

Locations
Egypt
Evangelical Synod Medical Centre
Cairo, Egypt, 11111
Sponsors and Collaborators
Evangelical Synod Medical Centre
Investigators
Principal Investigator: Ihab Akhnoukh Evangelical Synod Medical Centre
Study Director: Ashraf Khella Harpur Memorial Hospital
  More Information

No publications provided

Responsible Party: Dr Ihab Akhnoukh M.D., Evangelical Synod Medical Centre
ClinicalTrials.gov Identifier: NCT00568204     History of Changes
Other Study ID Numbers: EvangelicalSynodMC
Study First Received: November 30, 2007
Last Updated: October 16, 2013
Health Authority: Egypt: Institutional Review Board

Keywords provided by Evangelical Synod Medical Centre:
pruritus, itching, mexyn-a, clearitch, magicool-plus

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014