Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females (MEXISPATENT)
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Hair loss prevention lotion
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Baldness, Androgenetic Alopecia, Alopecia
Eligibility Criteria
Inclusion Criteria:
- Good state of general health
- Suffering from hair loss
- 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 Mexis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Volunteers
Arm Description
20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Allopecia in several types apply on the scalp drops of the hair loss prevention lotion
Outcomes
Primary Outcome Measures
Change of the Amount of Hair Loss in a Pull Test
Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers.
Measurements estimated and reported every 15 days. The Measure reports decrease in fallen hair
Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.
Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments
Secondary Outcome Measures
Change of Sebum on a Sebum-meter
Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01701271
Brief Title
Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females
Acronym
MEXISPATENT
Official Title
Evaluation of the Efficacy of the Cosmetic Lotion M.P.A.F. (Mixture of Paraffin, Alcohol and Fur) MEXIS PATENT in the Treatment of Androgenetic Alopecia by Decreasing of Hair Loss and Strengthening and Thickening of Hair in Males and Females.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
June 2001 (Actual)
Study Completion Date
June 2001 (Actual)
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 Androgenetic Alopecia.
Detailed Description
This study verifies whether the tested product has any efficacy in the treatment of Androgenetic Alopecia.
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 have been selected for this test .
Samples of the product have been applied following their usual use: as they are.
On the selecting volunteers have been used:
The pull test by pulling with fingers of some hair and counting them to estimate the evolution of the pathology.
A sebum-meter to check the presence of scales on the scalp.
A polarized light video-camera to check the redness of the scalp and to have a picture of hair and scalp.
Volunteers were also asked about:
Fluffiness
Sheen
Itching
Presence of scales on scalp
Oily hair
Product's acceptability
The readings are 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 were taken during experimentation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
Baldness, Androgenetic Alopecia, Alopecia
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 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Volunteers
Arm Type
Experimental
Arm Description
20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Allopecia in several types apply on the scalp drops of the hair loss prevention lotion
Intervention Type
Other
Intervention Name(s)
Hair loss prevention lotion
Intervention Description
For greatest problems 20 drops on the scalp per day for 3 months. For minor problems 10 drops on the scalp three times per week for 3 months.
Primary Outcome Measure Information:
Title
Change of the Amount of Hair Loss in a Pull Test
Description
Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers.
Measurements estimated and reported every 15 days. The Measure reports decrease in fallen hair
Time Frame
baseline and 90 days
Title
Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.
Description
Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments
Time Frame
baseline and 90 days
Secondary Outcome Measure Information:
Title
Change of Sebum on a Sebum-meter
Description
Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter.
Time Frame
baseline and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Good state of general health
Suffering from hair loss
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fulvio Marzatico, Monitor
Organizational Affiliation
Bio Basic EuropeResearch, Development and Dermo-Cosmetoligical Documentation
Official's Role
Study Chair
Facility Information:
Facility Name
George Mexis
City
Athens
ZIP/Postal Code
11253
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females
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