Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females

Alopecia Areata Clinical Trial

— MEXISAREATA  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02604888
• Other study ID #: MEXIS-ALOPECIA AREATA-2015
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2015
• Last updated: January 3, 2017
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: January 2017
• Source: Mexis George
• Contact: Sandy Matzakoni, Controller
• Email: info[@]mexis.gr
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the Hair Loss Prevention Lotion named MEXIS, M.P.A.F., M6S PATENT is effective in the treatment of Alopecia Areata.

Description:

This study verifies whether the tested product has any efficacy in the treatment of Alopecia Areata.

• The evaluated product (Hair Loss prevention Lotion) is called: MEXIS, MPAF, M6S PATENT.

• 20 volunteers both men and women suffering from hair loss both in parties and over the entire scalp with age between 18 and 70 years will be selected for this test .

• Samples of the product have been applied following their usual use: as they are.

• On the selecting volunteers will be used:

A polarized light video-camera to check the redness of the scalp and to have a picture of hair and scalp.

• Volunteers will also be asked about:

• Fluffiness

• Sheen

• Itching

• Presence of scales on scalp

• Oily hair

• Product's acceptability

• The readings will be taken at 0 time (basal value), after 15 days (t15), 30 days (t30), 45 days (t45), 45 days (t45), 60 days (t60) and 90 days (t90) by the experimenter in the medical studio. Then they analyzed and reported in a graph.

• Summarizing tables and graphs of the data will be taken during experimentation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Good state of general health

• Suffering from Alopecia Areata

• No pharmacological treatment in progress

• Promise not to change the usual daily routine

• No atopy in the anamnesis

Exclusion Criteria:

• Illness

• Good state of hair

• Pharmacological treatment in progress

• Denial of the continuance of the usual daily routine

• Atopy in the anamnesis

Study Design

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Other:
• MEXIS/M6S Patent - lotion against alopecia
For greatest problems 20 drops on the scalp per day for 6 months. For minor problems 10 drops on the scalp three times per week for 6 months.

Locations

Country	Name	City	State
Greece	George Mexis	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Mexis George

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the Density of the Hair measured with a camera	Change on the total amount of head's hair	baseline and 180 days	No
Secondary	Change of the Amount of Hair Loss	Change on the amount of hair fallen per day	baseline and 180 days	No