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

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.

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.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Other: Hair loss prevention lotion

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11253
    • George Mexis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volunteers; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mexis George
• Investigators: Study Chair: Fulvio Marzatico, Monitor, Bio Basic EuropeResearch, Development and Dermo-Cosmetoligical Documentation

Study record dates

Study Major Dates

• Study Start: February 1, 2001
• Primary Completion (Actual): June 1, 2001
• Study Completion (Actual): June 1, 2001

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: October 3, 2012
• First Posted (Estimate): October 5, 2012

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: January 20, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Baldness; Androgenetic Alopecia; Alopecia
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: MEXIS-HAIR LOSS-STUDY 1.2012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No