Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females (MEXISAREATA)
Primary Purpose
Alopecia Areata
Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
MEXIS/M6S Patent - lotion against alopecia
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata focused on measuring Baldness, Alopecia Areata, Alopecia, Hair loss
Eligibility Criteria
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
Sites / Locations
- George MexisRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Volunteers
Arm Description
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
Outcomes
Primary Outcome Measures
Change of the Density of the Hair measured with a camera
Change on the total amount of head's hair
Secondary Outcome Measures
Change of the Amount of Hair Loss
Change on the amount of hair fallen per day
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02604888
Brief Title
Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females
Acronym
MEXISAREATA
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mexis George
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Baldness, Alopecia Areata, Alopecia, Hair loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Volunteers
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
MEXIS/M6S Patent - lotion against alopecia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of the Density of the Hair measured with a camera
Description
Change on the total amount of head's hair
Time Frame
baseline and 180 days
Secondary Outcome Measure Information:
Title
Change of the Amount of Hair Loss
Description
Change on the amount of hair fallen per day
Time Frame
baseline and 180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandy Matzakoni, Controller
Ext
0030
Email
info@mexis.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markos Papakonstantis, Monitor
Organizational Affiliation
401 General Military Hospital of Athens, Dermatology clinic
Official's Role
Study Chair
Facility Information:
Facility Name
George Mexis
City
Athens
ZIP/Postal Code
11253
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matzakonis Sandy, Supervisor
Phone
2108623547
Ext
0030
Email
info@mexis.gr
First Name & Middle Initial & Last Name & Degree
Markos Papakonstantis, Controller
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females
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