Efficacy Study of a Cosmetic Lotion in the Treatment of Androgenetic Alopecia in Males and Females

Androgenetic Alopecia Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701271
• Other study ID #: MEXIS-HAIR LOSS-STUDY 1.2012
• 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

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

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