Study of Effectiveness of Mexyn-A

Pruritus Clinical Trial

— Mexyn-A  

Official title:

Proof of Concept of MEXYN-A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568204
• Other study ID #: EvangelicalSynodMC
• Status: Completed
• Phase: N/A
• First received: November 30, 2007
• Last updated: October 16, 2013
• Start date: March 2002
• Est. completion date: September 2005

Study information

• Verified date: October 2013
• Source: Evangelical Synod Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pruritus

Intervention

Device:
• Mexyn-A
Atomised topical self-chilled pressurised spray

Locations

Country	Name	City	State
Egypt	Evangelical Synod Medical Centre	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Evangelical Synod Medical Centre

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treating Pruritus		three days	Yes
Secondary	measuring itch-free period after applying the new treatment, effect on sleep disturbance		three days	Yes