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

January 3, 2017 updated by: Mexis George
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

Study Locations

  • Greece
      • Athens, Greece, 11253
        • Recruiting
        • George Mexis
        • Contact:
          • Matzakonis Sandy, Supervisor
          • Phone Number: 0030 2108623547
          • Email: info@mexis.gr
        • Principal Investigator:
          • Markos Papakonstantis, Controller

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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
Other: Volunteers
20 volunteers both men and women with an age between 18 and 70 years suffering from Alopecia Areata in several types apply on the scalp drops of the MEXIS/M6S PATENT - lotion against Alopecia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the Density of the Hair measured with a camera
Time Frame: baseline and 180 days
Change on the total amount of head's hair
baseline and 180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the Amount of Hair Loss
Time Frame: baseline and 180 days
Change on the amount of hair fallen per day
baseline and 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mexis George

Investigators

  • Study Chair: Markos Papakonstantis, Monitor, 401 General Military Hospital of Athens, Dermatology clinic

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

October 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

November 11, 2015

First Posted (Estimate)

November 16, 2015

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEXIS-ALOPECIA AREATA-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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