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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mexis George
ClinicalTrials.gov Identifier:
NCT01701271
First received: October 1, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to determine whether the Hair Loss Prevention Lotion named MEXIS,MPAF, M6S PATENT is effective in the treatment of Androgenetic Alopecia.


Condition Intervention
Androgenetic Alopecia
 Other: Hair loss prevention lotion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of the Hair Loss Prevention Cosmetic Lotion MPAF MEXIS M6S PATENT in the Treatment of Androgenetic Alopecia by Decreasing of Hair Loss and Strengthening and Thickening of Hair in Males and Females.

Resource links provided by NLM:

MedlinePlus related topics: Cosmetics
U.S. FDA Resources

Further study details as provided by Mexis George:

Primary Outcome Measures:
  • Decrease of hair loss in a pull test and thickening of hair on a polarized light video-camera as a measure of Efficacy [ Time Frame: 90 days ] [ Designated as safety issue: No ]

    Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers and of the thickening of hair with the polarized light video-camera.

    Measurements estimated and reported every 15 days.



Secondary Outcome Measures:
  • Decrease of sebum on a sebum-meter, of dandruff, redness and oiliness on a polarized light video-camera as a measure of Efficacy [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter and of the decrease of dandruff, redness and oiliness on the scalp of the volunteers with a polarized light video-camera.


Enrollment: 20
Study Start Date: February 2001
Study Completion Date: June 2001
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701271

Locations
Greece
George Mexis
Athens, Greece, 11253
Sponsors and Collaborators
Mexis George
Investigators
Study Chair: Fulvio Marzatico, Monitor Bio Basic EuropeResearch, Development and Dermo-Cosmetoligical Documentation
  More Information

No publications provided

Responsible Party: Mexis George
ClinicalTrials.gov Identifier: NCT01701271     History of Changes
Other Study ID Numbers: MEXIS-HAIR LOSS-STUDY 1.2012
Study First Received: October 1, 2012
Last Updated: October 3, 2012
Health Authority: Greece: National Organization of Medicines

Keywords provided by Mexis George:
Baldness
Androgenetic Alopecia
Alopecia

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013