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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volunteers | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hair loss prevention lotion | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and 90 days |
| 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 | baseline and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fulvio Marzatico, Monitor | Bio Basic EuropeResearch, Development and Dermo-Cosmetoligical Documentation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Mexis | Athens | 11253 | Greece |
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The recruitment started on February 2001 at the University of studies of Pavia
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| ID | Title | Description |
|---|---|---|
| FG000 | Volunteers Evaluated | 20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Volunteers | 20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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 | Posted | Mean | Full Range | Fallen hair | baseline and 90 days |
|
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No adverse events were assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Volunteers | 20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Fulvio Marzatico | Bio Basic Europe | (39) 0382 - 506390 | fulviomk@unipv.it |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Good state of general health Suffering from hair loss | Posted | Mean | Full Range | mg sebum/c^2 | baseline and 90 days |
|
|
|
| Primary | 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 | 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 | Posted | Mean | Full Range | hairs/square inch | baseline and 90 days |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |