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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01701271
Other study ID # MEXIS-HAIR LOSS-STUDY 1.2012
Secondary ID
Status Completed
Phase N/A
First received October 1, 2012
Last updated January 20, 2016
Start date February 2001
Est. completion date June 2001

Study information

Verified date January 2016
Source Mexis George
Contact n/a
Is FDA regulated No
Health authority Greece: National Organization of Medicines
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2001
Est. primary completion date June 2001
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Hair 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.

Locations

Country Name City State
Greece George Mexis Athens

Sponsors (1)

Lead Sponsor Collaborator
Mexis George

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
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
baseline and 90 days No
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 baseline and 90 days No
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. baseline and 90 days No
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