Androgenetic Alopecia
Conditions
Keywords
Baldness, Androgenetic Alopecia, Alopecia
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: 1. The pull test by pulling with fingers of some hair and counting them to estimate the evolution of the pathology. 2. A sebum-meter to check the presence of scales on the scalp. 3. 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.
Interventions
OTHERHair loss prevention lotion
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.
Sponsors
Mexis George
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Amount of Hair Loss in a Pull Test | baseline and 90 days | 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. | baseline and 90 days | Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Sebum on a Sebum-meter | baseline and 90 days | Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter. |
Countries
Greece
Participant flow
Recruitment details
The recruitment started on February 2001 at the University of studies of Pavia
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Volunteers |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 26 |
| Region of Enrollment Italy | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: baseline and 90 days
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Volunteers | Change of the Amount of Hair Loss in a Pull Test | 2.75 Fallen hair |
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
Time frame: baseline and 90 days
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Volunteers | Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy. | 2.75 hairs/square inch |
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.
Time frame: baseline and 90 days
Population: Good state of general health Suffering from hair loss
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Volunteers | Change of Sebum on a Sebum-meter | 8.8 mg sebum/c^2 |